Last updated: 2025-05-22

67 Quality Assurance And Engineering jobs in Remote - United States.

Hiring now: Vice President Technical @ Parexel, Associate Dir Inspection @ Regeneron , Qa Mgr @ Radformati, Mgr Corporate Quality Pos @ Ro, Services Engagement Mgr Q @ Veeva Syst, Regulatory Spec Fragrance @ Osmo, Quality Assurance Associa @ Nutrafol, Sr Quality Auditor @ Precisionm, Prod Mgr Community Hospit @ Altera Dig, Spec Qa @ Amgen.Explore more at at kaamvaam.com

🔥 Skills

compliance (12) Quality Assurance (11) risk management (10) Regulatory Affairs (9) Project Management (9) regulatory compliance (9) quality assurance (9) FDA (7) Medical Device (6) training (6)

📍 Locations

United States (67)
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Parexel

Vice President, Technical - Medical Device Luminary United States
Skills & Focus: Vice President, Technical, Medical Device, Regulatory Affairs, Biologics, Clinical, Project Management, Consulting, FSP, Clinical Operations
Type: Consulting
Vice President, Technical - Medical Device Luminary United States
Skills & Focus: Vice President, Technical, Medical Device, Regulatory Affairs, Biologics, Clinical, Project Management, Consulting, FSP, Clinical Operations
Type: Consulting
Vice President, Technical - Medical Device Luminary United States
Skills & Focus: Vice President, Technical, Medical Device, Regulatory Affairs, Biologics, Clinical, Project Management, Consulting, FSP, Clinical Operations
Type: Consulting

Regeneron Pharmaceuticals Inc.

Associate Director Inspection Management (GCP) United States
Skills & Focus: GCP, GVP, GLP, inspections, stakeholder engagement, regulatory compliance, quality management, clinical trials, training, risk mitigation
Experience: 10 years
Salary: $154,800.00 - $252,800.00
Type: Contract
Benefits: health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off

Radformation

QA Manager United States
Skills & Focus: QA Manager, Radiation Oncology, Quality Assurance, Medical Device, Testing, Automation, Clinical skills, Product Management, Troubleshooting, Product Development
About the Company: Radformation specializes in Radiation Oncology Cancer treatment workflow automation, aiming to deliver reliable, high-quality, automated solutions that allow c…
Type: Full-time

Ro

Manager, Corporate Quality (Post-Market, External Partnerships and Testing) United States
Skills & Focus: quality assurance, compliance, innovation, external partnerships, testing facilities, post-market, technical transfer, go-to-market, suppliers, third-party pharmacy
About the Company: Ro is a direct-to-patient healthcare company with a mission of helping patients achieve their health goals by delivering the easiest, most effective care possi…

Veeva Systems

Services Engagement Manager - Quality Cloud United States
Skills & Focus: Quality Cloud, implementation, consulting services, Life Sciences, proposals, stakeholder engagement, software implementation, project charter, GxP Training, compliance
About the Company: Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the…
Experience: 5+ years of experience delivering consulting services
Salary: $85,000 - $170,000
Type: Full-time
Benefits: Medical, dental, vision, and basic life insurance; Flexible PTO and company paid holidays; Retirement programs; 1% char…

Osmo

Regulatory Specialist, Fragrance Manufacturing United States
Skills & Focus: regulatory compliance, fragrance, SDS preparation, IFRA, REACH, FDA, EPA, technical documentation, product registrations, risk assessments
About the Company: Osmo is a digital olfaction company focused on enhancing human health and wellbeing through the power of smell.
Experience: Minimum of 3-5 years of experience in regulatory affairs
Type: Full time

Nutrafol

Quality Assurance Associate United States
Skills & Focus: Quality Assurance, GMP compliance, dietary supplements, FDA regulations, product quality, complaints processing, Supplier Qualification, Certificates of Analysis, critical thinking, collaboration
About the Company: Nutrafol is a company focused on hair wellness, creating clinically tested products for hair growth and supporting people throughout their hair journey. They a…
Experience: 3+ years of direct US dietary supplement/Consumer Healthcare Quality experience
Salary: $70,000 - $85,000 USD
Type: Full-time
Benefits: Fully remote work experience, Comprehensive medical, dental, and vision package, including FSA program, 401K with 50% m…

Precisionmedicinegroup

Senior Quality Auditor United States
Skills & Focus: Quality Management System, SOPs, CAPA, documentation, training, client audits, regulatory inspections, vendor audits, internal audits, compliance
Experience: 4 years industry experience

Altera Digital Health Inc.

Product Manager - Community Hospitals / Regulatory United States
Skills & Focus: Product Management, Healthcare IT, Regulatory Compliance, FHIR, Interoperability, Agile Methodologies, HL7 Standards, CMS, TJC, Regulatory Strategy
About the Company: Altera, a member of the N. Harris Computer Corporation family, delivers health IT solutions that support caregivers around the world.
Experience: 5+ years of experience in healthcare IT or a related field, 3+ years of product management experience
Salary: $90,000 - $110,000 USD
Type: Remote

Amgen

Specialist QA United States
Skills & Focus: quality assurance, product quality, GMP systems, collaboration, document approval, deviation investigations, root cause analysis, CAPAs, international quality, clinical products
About the Company: Amgen is a biotech company focused on serving patients living with serious illnesses by researching, manufacturing, and delivering innovative medicines.
Salary: 109,307.00 USD - 129,509.00 USD
Type: Full-time

Mind Medicine

Senior Manager, GCP QA United States
Skills & Focus: GCP, QA, Quality Assurance, Clinical Trials, Audits, Regulatory Compliance, SOPs, Risk Management, Investigations, Training
About the Company: MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders.
Experience: 7+ years working in GCP Quality Assurance and Clinical Program Management
Salary: $140,000.00 - $173,116.00
Type: Full-time
Benefits: 100% paid health benefits including Medical, Dental and Vision for you and your dependents, 401(k) program with company…

Cardinal Health

International Regulatory Affairs Manager United States
Skills & Focus: Regulatory Affairs, pharmaceutical, medical, biotechnology, regulatory submissions, clinical research, government approvals, product development, team leadership, stakeholder management
About the Company: Cardinal Health provides regulatory affairs and product development consulting services to enable pharmaceutical, medical and biotechnology companies to obtain…
Experience: 8-12 years of experience
Salary: $103,500 - $155,295
Type: Full time
Benefits: Medical, dental and vision coverage, Paid time off plan, Health savings account (HSA), 401k savings plan, Access to wag…

Amgen

Sr. Manager IVD Strategy & Operations - Precision Medicine Unit United States
Skills & Focus: IVD, strategy, operations, regulatory, cross-functional, coordination, training, performance tracking, collaboration, change management
About the Company: Amgen's shared mission is to serve patients living with serious illnesses, pioneering the world of biotech since 1980.
Experience: 7+ years of experience in biopharma, with a focus on clinical operations, R&D-related roles, regulatory affairs, project management, or cross-functional coordination
Salary: 141,928.00 USD - 171,979.00 USD
Type: Full time

Veeva Systems

Proposal Manager - R&D and Quality United States
Skills & Focus: Proposal Management, Life Sciences, SaaS, RFx, Response Lifecycle, Cross-functional Collaboration, Content Development, Project Management, Quality Assurance, Technical Communication
About the Company: Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the…
Experience: 4+ years of proposal management experience in a dynamic B2B environment, preferably in life sciences and/or SaaS
Salary: $75,000 - $115,000
Type: Full-time
Benefits: Medical, dental, vision, life insurance, Flexible PTO, holidays, retirement programs, charitable giving program

Regeneron Pharmaceuticals Inc.

Senior Editor United States
Skills & Focus: Senior Editor, regulatory submission documents, quality control, nonclinical, editing, QC checklists, drug development, communication skills, document management platforms, bioanalytical sciences
Experience: Minimum of 4 years of experience editing, formatting, drafting, or reviewing regulatory submission documents
Salary: $70,700.00 - $115,100.00
Type: Contract
Benefits: health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off

Biomarin Pharmaceutical Inc.

Director, Product Quality Leader United States
Skills & Focus: quality leadership, regulatory guidelines, product quality, CMC team, risk management, clinical development, commercialization, team collaboration, pharmaceuticals, biotechnology
About the Company: BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future o…
Experience: 12+ years of experience with Biotechnology, Pharmaceutical, Medical Device or other, highly regulated, industry; preferred experience in gene therapy or biologics product development and licensure or technical support.

Ardelyx

Executive Director, Quality Management and GxP Systems United States
Skills & Focus: Quality Management Systems, GxP Systems, Regulatory Compliance, FDA Regulations, Quality Assurance, Risk Management, Vendor Qualification, Auditing, CAPA, Process Improvement
About the Company: Ardelyx is a publicly traded commercial biopharmaceutical company focused on discovering, developing, and commercializing innovative medicines for unmet medica…
Experience: 15+ years in pharmaceutical quality systems and GxP Systems; 10+ years in a Quality environment
Salary: $257,000-$314,000 annually
Type: Full-time
Benefits: Health plans, 401(k) with employer match, paid parental leave, paid holidays, among others.

Bridgebio Pharma

Sr. Manager, Quality Assurance United States
Skills & Focus: Quality Assurance, GMP, Document Control, Deviations, CAPA, Training, Batch Record Review, System Validation, Collaboration, Problem Solving
About the Company: BridgeBio Pharma focuses on discovering and developing drugs for patients with grievous rare genetic diseases by finding the right starting points to target di…
Experience: Minimum of 7 years pharmaceutical industry experience in Quality Assurance or other relevant roles
Salary: $150,000 - $180,000 USD
Type: Full-time
Benefits: Comprehensive health care with 100% premiums covered, unlimited flexible paid time off, 401K with employer match, emplo…

Penumbra

Clinical Research Associate II (CRA II) United States
Skills & Focus: clinical studies, site management, monitoring functions, compliance, regulatory guidelines, device accountability, audit readiness, protocols, mentoring, Quality Management System (QMS)
Experience: 3+ years of experience in clinical/scientific research, nursing, or medical devices/pharmaceutical industry; 1+ years of clinical monitoring experience
Salary: $89,000 - $130,000
Type: Full-time
Benefits: Competitive compensation package plus benefits and equity program

Altoida

Head of Regulatory Affairs and Quality United States
Skills & Focus: regulatory strategy, Quality Management System, FDA, regulatory submissions, AI/ML-enabled digital biomarkers, compliance, regulatory intelligence, post-market surveillance, cross-functional collaboration, product design
About the Company: Altoida is defining a new category in neurological care with a multi-modal platform combining AR, sensor fusion, and AI for cognitive and functional diagnostic…

Apogee Therapeutics, Inc.

Director, Computer System Validation - Quality Assurance (CSV QA) United States
Skills & Focus: computing system validation, quality assurance, biotechnology, pharmaceutical, regulatory compliance, risk management, data integrity, leadership, cross-functional collaboration, validation documentation
About the Company: Apogee Therapeutics is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonar…
Experience: Minimum of 10 years of experience in computer system validation (CSV) within a biotechnology, pharmaceutical, and/or medical device industry with at least 3 years in a leadership role focused on quality assurance.
Salary: $200,000 - $225,000/year
Type: Full-time
Benefits: Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunit…

Pfizer

Associate - Manufacturing Compliance United States
Skills & Focus: manufacturing, compliance, training management, cGMP, audits, CAPA, process improvement, pharmaceuticals, SAP, software
About the Company: Pfizer is a global pharmaceutical corporation dedicated to discovering and developing innovative medicines and vaccines.
Experience: More than 2+ years of experience in pharmaceuticals industry
Type: Full-time

Formation Bio

Director, Medical Writing United States
Skills & Focus: medical writing, clinical development, regulatory documents, pharmacovigilance, cross-functional teams, AI tools, Good Clinical Practice, document author, stylish guidelines, continuous improvement
About the Company: Formation Bio is a tech and AI driven pharma company focused on radically more efficient drug development, utilizing technology platforms and AI advancements t…
Experience: 7+ years in the development of clinical and regulatory documents
Salary: $250,000 - $300,000 for NYC and Boston; $238,000 - $285,000 for other eligible remote locations
Type: Hybrid
Benefits: Equity, generous perks, hybrid flexibility, comprehensive benefits

Biomarin Pharmaceutical Inc.

Director, Product Quality Leader United States
Skills & Focus: product quality, biotechnology, regulatory, clinical development, commercialization, quality assurance, risk management, cross-functional, stakeholder engagement, cGMP
About the Company: BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future o…
Experience: 12+ years of experience with Biotechnology, Pharmaceutical, Medical Device or other, highly regulated, industry; preferred experience in gene therapy or biologics product development

Ardelyx

Associate Director, Pharmacovigilance United States
Skills & Focus: pharmacovigilance, drug safety, regulatory compliance, case processing, quality assurance, adverse event reporting, SOPs, aggregate reports, internal audits, vendor management
About the Company: Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medic…
Experience: 8 – 10 years
Salary: $180,000-$220,000
Type: Full-time
Benefits: 401(k) plan with generous employer match, 12 weeks of paid parental leave, health plans, life insurance and disability,…

Boston Scientific

Medical Device Toxicologist II United States
Skills & Focus: toxicology, biocompatibility, ISO 10993, medical devices, regulatory standards, toxicity assessments, biological evaluation, risk assessment, glp studies, medical device development
About the Company: A leader in medical science for over 40 years, committed to solving healthcare challenges with innovative solutions to improve patient lives.
Experience: 2-3 years supporting medical devices
Salary: $72,800 - $138,300
Type: Hybrid (Onsite and Remote)

Immunovant, Inc.

Director, Clinical Supply, CMC QA United States
Skills & Focus: quality assurance, GXP procedures, clinical supply chain, product approvals, compliance risks, technical documentation, risk management, unblinding event investigation, inspections readiness, vendor management
About the Company: Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn t…
Experience: minimum of 8+ years of hands-on experience in the pharmaceutical industry
Salary: $200,000 - $215,000 USD
Type: Remote
Benefits: a full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave

Loyal

Senior Manager, Quality United States
Skills & Focus: GxP compliance, quality assurance, veterinary drug products, FDA, audits, continuous improvement, risk assessments, regulatory requirements, quality management system, collaboration
About the Company: Loyal is a clinical-stage veterinary medicine company developing drugs intended to extend the lifespan and healthspan of dogs. Our mission is to help dogs live…
Experience: Minimum 10 years of relevant pharmaceutical industry experience, with at least 6 years in GxP QA roles.
Salary: $140,000 - $170,000
Type: Full-time
Benefits: Full-coverage health insurance, $1,000 home office equipment stipend, $1,200/year learning budget, $250/month wellness …

Heartflow

Senior Quality Engineer United States
Skills & Focus: medical device, quality requirements, risk management, ISO 13485, ISO 14971, 21 CFR 820, CAPA, audits, project management, cross-functional collaboration
About the Company: Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease using cutting-edge technology.
Experience: 6-8 years
Salary: $115,000 - $160,000
Type: Full-time
Benefits: Cash bonus and stock options

Johnson & Johnson

Sr Regulatory Affairs Specialist (Remote) - Shockwave United States
Skills & Focus: Regulatory, Medical Device, Clinical Documentation, International Regulatory, Registration, Compliance, Submission, Quality, Standards, Project Management
About the Company: A multinational corporation developing medical devices, pharmaceuticals, and consumer health products.
Experience: Minimum 5 years of regulatory affairs experience in the medical device industry
Director, SQ Drug Delivery Systems United States
Skills & Focus: Supplier Quality Management, Drug Delivery Systems, Quality Assurance, Regulatory Compliance, Quality Culture, Performance Metrics, Risk Assessments, Supplier Agreements, Team Leadership, Strategic Thinking
About the Company: Johnson & Johnson is a global healthcare company specializing in pharmaceuticals, medical devices, and consumer health products. Their mission is to improve he…
Experience: A minimum of 12+ years experience in biologics, drug product, drug substance, medical device, vaccines or similar regulated environment.
Type: Hybrid

Amgen

Development Transformation Lead, Director United States
Skills & Focus: clinical trial, documentation framework, regulatory compliance, SOPs, transformation strategy, process documentation, cross-functional, operational excellence, quality, change management
About the Company: Amgen is a biotechnology company focused on serving patients living with serious illnesses through the development of innovative medicines.
Salary: 179,156.00 USD - 211,501.00 USD
Type: Full time

Pfm

Senior Quality Auditor United States
Skills & Focus: auditing, compliance, clinical research, quality management, SOPs, training, CAPA, regulatory inspections, vendor audits, quality systems
Experience: 4 years industry experience

Johnson & Johnson

Technical Fellow (Director), Advanced Therapies - MSAT United States
Skills & Focus: CAR-T manufacturing, Quality Control, cell processing, regulatory compliance, manufacturing trend investigation, root cause analysis, process development, biosafety standards, biopharmaceutical manufacturing, advanced therapies
About the Company: A multinational corporation with focus on healthcare, pharmaceuticals, and medical devices.

Baxter

Various Open Positions in Sales and Quality United States
Skills & Focus: Sales, Quality, Medical Devices, Pharmaceuticals, Regulatory Affairs, Innovative Solutions, Healthcare, Customer Support, Clinical Education, Diversity and Inclusion
About the Company: Baxter is a healthcare company that innovates, manufactures, and delivers medical devices and solutions aimed at saving and sustaining lives.
Type: Full-time
Benefits: Comprehensive benefits options reflecting the value placed in employees.

Foresight Diagnostics Inc.

Senior Director, Quality United States
Skills & Focus: quality culture, regulatory compliance, CLIA, CAP, FDA, EU EMA, quality management system, risk management, regulatory inspections, team leadership
About the Company: Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company developing non-invasive cancer detection technologies using cell-free DNA…
Experience: 10+ years, with at least 3 years overseeing quality in clinical laboratories with CAP accreditation
Salary: $230,000 - $250,000
Type: Full-time
Benefits: Paid vacation, sick time, parental leave, medical, dental, vision, life, disability coverage, flexible spending account…

Baxter

Medical Writer United States
Skills & Focus: Quality Assurance, Medical Writing, Healthcare, Clinical Research, Compliance, Regulatory Affairs, Patient Care, Innovation, Manufacturing, Diversity
About the Company: Baxter is a global medical device company that produces products designed to save and sustain lives.
Type: Full-time
Benefits: comprehensive benefits options

Perrigo

CMC Regulatory Affairs Project Manager United States
Skills & Focus: CMC Regulatory Affairs, project management, healthcare products, medical devices, cosmetics, regulatory strategies, product development, quality management, technical documentation, compliance
About the Company: We are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the …
Experience: Minimum of 7 years of relevant work experience, preferably in CMC Regulatory Affairs or R&D.
Benefits: Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career dev…

Peloton

Sr. FATP Supplier Quality Engineer - Contractor United States
Skills & Focus: Supplier Quality Engineer, Quality Management Systems (QMS), ISO9001, Supplier audits, Continuous Improvement, 8D problem-solving, GMP, Lean/Six Sigma, Process validation, CAD tools
About the Company: Peloton (NASDAQ: PTON) provides Members with expert instruction, and world class content to create impactful and entertaining workout experiences for anyone, a…
Experience: 5+ years of experience working as a supplier quality engineer in a similar fast-paced industry
Type: Contract

Regeneron Pharmaceuticals Inc.

Associate Manager, QA Auditor United States
Skills & Focus: GxP, regulatory, audits, QA, compliance, FDA, EU, process, vendor, regulations
Experience: 4+ years
Salary: $96,700.00 - $157,700.00

Sgs

Senior Medical Device Auditor United States
Skills & Focus: Senior Medical Device Auditor, audits, ISO 13485, MDSAP, MDD, MDR, medical devices, audit teams, certification, training
Experience: Must have experience with ophthalmology medical devices

Iqvia

Associate Director, IT Compliance United States
Skills & Focus: IT Compliance, Validation, GxP, regulations, risk management, audit, client service, regulatory guidance, Foster system lifecycle, Quality Assurance
About the Company: IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industrie…
Experience: Substantial experience in healthcare, life sciences (Pharma, CROs), related product or service industry.
Type: Full time
Benefits: Benefits programs are designed to meet your total well-being needs so you can thrive at work and at home.

Radformation

QA Manager United States
Skills & Focus: QA Manager, Radiation Oncology, quality assurance, product quality management, treatment planning, AI-driven contours, testing, troubleshooting, medical physicist, Regulatory Team
About the Company: Radformation specializes in Radiation Oncology Cancer treatment workflow automation. Our solutions impact cancer clinics around the world by saving time, elimi…
Experience: Highly motivated medical physicist with a passion for radiation therapy
Type: Full-time

Imvt Corporation

Associate Director, CMC QA United States
Skills & Focus: CMC, Quality Assurance, GMP, lot disposition, biopharmaceutical, FDA, clinical trials, regulations, batch review, process improvement
About the Company: Immunovant is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases.
Experience: Minimum of eight (8) years of GMP experience in QA with substantial operational experience in drug substance and drug product manufacture. Minimum of five (5) years in roles of increasing responsibility in a biopharmaceutical environment; a minimum of two (2) years managing drug substance/drug product facilities.
Salary: $170,000 - $180,000 USD
Benefits: Full range of medical, dental, vision, 401k, unlimited paid time off, parental leave, and other benefits.

Bridgebio Pharma

Sr. Manager/Associate Director, Regulatory Program Management United States
Skills & Focus: regulatory management, project management, biotech, NDA, MAA, Veeva RIM, eCTD, filings, timeline management, critical thinking
About the Company: BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic dise…
Experience: 3+ years in regulatory project management
Salary: $150,000 - $220,000 USD
Type: Full-time
Benefits: Robust and market-competitive compensation & benefits package including Base, Performance Bonus, Equity, health, welfar…

Novartis

Project Engineer for US projects (m/f/d) United States
Skills & Focus: Project Engineering, Aseptic Operations, Technical Documentation, Cost Estimation, Supplier Management, Risk Assessment, Qualification Protocols, Compliance, Project Strategy, GMP
About the Company: Novartis is an innovative medicines company dedicated to reimagining medicine to improve and extend people’s lives.
Type: Full-time

Orca Bio

Sr. Specialist, Regulatory Affairs United States
Skills & Focus: regulatory affairs, clinical trials, FDA, EMA, regulatory submissions, compliance, oncology, cell therapy, ICH/GCP guidelines, adverse events
About the Company: Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing signif…
Experience: Minimum of 3 years of experience in regulatory affairs, supporting clinical trials.
Type: Full-time

Johnson & Johnson

Regulatory Affairs Professional, CMC Certificates and Samples - Business Support United States
Skills & Focus: Regulatory Affairs, CMC, Certificates, Samples, Pharmaceutical, GMP, Registration activities, Cross-functional team, Global submissions, Documentation
About the Company: A global healthcare company committed to improving health for humanity through innovative products and solutions.
Experience: At least 2 years professional experience in relevant field
Type: Full-time
Benefits: Comprehensive health insurance, retirement plans, paid time off, employee discounts, and wellness programs.

Dentsply Sirona, Inc

Director Center of Excellence Clinical Research United States
Skills & Focus: clinical research, dental industry, product development, ISO 14155, MDR, medical device, team management, investigator-initiated studies, scientific communication, regulatory compliance
About the Company: Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the …
Experience: Minimum of 10+ years of experience in clinical research with a focus on dentistry.

Mcra, An Iqvia Business

Director, Cardiovascular Regulatory Affairs United States
Skills & Focus: director, regulatory affairs, cardiovascular, regulatory strategy, submissions, project management, mentoring, training, healthcare compliance, medical devices
About the Company: MCRA is a leading medical device advisory firm and clinical research organization (CRO) focused on integrating regulatory, clinical research, reimbursement, he…
Experience: Various experience in regulatory submissions and strategy management
Type: Full-time

Veeva Systems

Senior Consultant - Quality Cloud United States
Skills & Focus: Cloud-based, Life sciences, Quality Management, SaaS, GxP, Implementation, IT Operations, Project Management, Content Management, Healthcare
About the Company: Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the…
Experience: 8+ years in IT Project Management, GMP Systems ownership, or Software Consulting
Salary: $80,000 - $200,000
Type: Full-time
Benefits: Medical, dental, vision, and basic life insurance; Flexible PTO and company paid holidays; Retirement programs; 1% char…

Sgs

Product Assessor (Medical Devices - Active & Software) United States
Skills & Focus: Medical Devices, Technical File Reviews, CE Marking, Regulatory Compliance, Product Assessment, Medical Device Directive, Technical Documentation, Client Communication, Service Delivery, Risk Management
About the Company: SGS is the world's leading inspection, verification, testing and certification company.

Regeneron Pharmaceuticals Inc.

Senior Manager, Regulatory Labeling United States
Skills & Focus: Regulatory labeling, labeling strategies, CCDS, USPI, EU SmPC, product lifecycle, FDA regulations, clinical trials, labeling documents, risk management
Experience: 3 - 4+ years of related Biotech or Pharma industry experience
Salary: $148,300.00 - $241,900.00
Type: Contract
Benefits: health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off

Hims & Hers

Principal Program Manager, Quality (PMO) United States
Skills & Focus: Project Management, Pharmaceutical Compounding, Quality Management Systems, Regulatory Requirements, Risk Management, Team Leadership, Stakeholder Management, Process Improvement, Compliance, Cross-functional Collaboration
About the Company: Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining health…
Experience: 12+ years of project management experience in the Pharmaceutical industry
Salary: $150K – $180K
Type: Full time
Benefits: Unlimited PTO, company holidays, and quarterly mental health days. Comprehensive health benefits including medical, den…

Formation Bio

Director, Quality Management Systems United States
Skills & Focus: pharmaceutical quality systems, QMS, regulatory compliance, cGMP, quality assurance, internal and external audits, corrective and preventive actions, cross-functional collaboration, quality metrics, leadership
About the Company: Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development. The company partners, acquires, or in-license…
Experience: 12+ years
Salary: $210,000 - $300,000
Type: Full-time
Benefits: Equity, generous perks, hybrid flexibility, comprehensive benefits.

Heartflow

Regulatory Specialist United States
Skills & Focus: Regulatory Affairs, regulatory requirements, cross-functional collaboration, product registrations, global regulatory approvals, FDA submissions, risk management, regulatory surveillance, Quality System management, medical device
About the Company: Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edg…
Experience: 1-3 years
Salary: $90,000 - $105,000
Type: Full-time
Benefits: cash bonus, stock options

Billiontoone

Director of Quality Management System United States
Skills & Focus: Quality Management System, Compliance, ISO13485, Continuous Improvement, Quality Assurance, Process Improvement, Team Leadership, Project Management, Regulatory Requirements, Cross-functional Collaboration
About the Company: BillionToOne is a next-generation molecular diagnostics company dedicated to developing powerful and accurate diagnostic tests that are accessible to all. Our …
Experience: 8+ years quality leadership experience
Salary: $357,408 per year, including a base pay range of $213,282 - $234,090 per year.
Type: Full-time
Benefits: Multiple medical benefit options, extremely generous family bonding leave, retirement savings program including a 4% co…

Hims & Hers

Sr. Manager, Quality Training & Education United States
Skills & Focus: quality training, pharmacy operations, compliance, regulatory, education, SOPs, GMP, capacity building, KPI development, internal audits
About the Company: Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining health…
Experience: 5+ years of experience in the pharmacy or compounding industry
Salary: $130K – $160K
Type: Full time
Benefits: Competitive salary & equity compensation, Unlimited PTO, comprehensive health benefits including medical, dental & visi…

Baxter

Research and Development Jobs United States
Skills & Focus: Research, Development, Healthcare, Engineering, Innovation, Medical Devices, Quality, Clinical, Manufacturing, Technology
About the Company: Baxter is a company that provides various healthcare solutions and is dedicated to saving and sustaining lives.
Type: Full time

Veeva Systems

Senior Consultant - Quality Cloud United States
Skills & Focus: cloud-based technology, Veeva Vault, Quality Management Systems, GxP principles, SaaS, Data Management, Content Management, Life Sciences, Implementation, Customer engagement
About the Company: Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. It is one of …
Experience: 8+ years in IT Project Management, GMP Systems ownership, or Software Consulting
Salary: $80,000 - $200,000
Type: Full-time
Benefits: Medical, dental, vision, and basic life insurance; Flexible PTO and company paid holidays; Retirement programs; 1% char…

Avanos Medical

Associate Director, Regulatory Affairs United States
Skills & Focus: regulatory strategy, compliance, EU MDR, medical devices, regulatory submissions, risk management, post-market activities, cross-functional collaboration, technical documentation, leadership
About the Company: Avanos Medical is a medical device company focused on delivering clinically superior breakthrough solutions that help patients get back to the things that matt…
Experience: A minimum of 8 years of experience in regulatory affairs within the medical device industry, or 5 years with an advanced degree, and with at least 3-5 years in a leadership or management role.
Type: Full-time

Cardinal Health

Director, Design Quality Engineering United States
Skills & Focus: Quality Management, Design Quality Management, Regulatory compliance, Product development, Risk management, Quality control, Process improvement, Strategic planning, Cross-functional collaboration, Medical device industry
About the Company: Cardinal Health, a global healthcare services and products company, provides pharmaceutical distribution and medical product solutions.
Experience: 12+ years of experience highly preferred
Salary: $114,200-$184,380
Type: Full time
Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being: Medical, dental and vi…

Precision Medicine Group

Associate Director, Regulatory Consultant United States
Skills & Focus: regulatory affairs, quality systems, marketing authorization, in vitro diagnostics, CDx, regulatory submissions, global clearance, business development, clinical protocols, FDA PMA
About the Company: Precision for Medicine applies high-level expertise and in-depth knowledge of regulatory affairs and quality systems to develop business solutions for clients …
Experience: Minimum 5+ years of experience in a medical device, pharmaceutical management, clinical trial, and/or pharmaceutical services consulting environment, or in vitro diagnostics, preferably with CDx.
Salary: $110,000 — $160,000 USD
Type: Full-time
Benefits: Discretionary annual bonus, health insurance, retirement savings benefits, life insurance, disability benefits, parenta…

Scholar Rock

Associate Director, Regulatory Labeling United States
Skills & Focus: regulatory labeling, labeling governance, labeling process, health authority interactions, core labels, CCDS, project management, scientific information, local labeling, continuous improvement
About the Company: Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unme…
Experience: 5+ years of direct experience in regulatory affairs global labeling
Type: Full-Time