Last updated: 2025-05-22

65 Quality Engineering jobs in Remote - United States.

Hiring now: Associate Dir Inspection @ Regeneron , Regulatory Affairs Consul @ Parexel, Qa Mgr @ Radformati, Mgr Corporate Quality Pos @ Ro, Services Engagement Mgr Q @ Veeva Syst, Regulatory Spec Fragrance @ Osmo, Sr Quality Auditor @ Precisionm, Spec Qa @ Amgen, Sr Mgr Gcp Qa @ Mind Medic, Dir Prod Quality Leader @ Biomarin P.Explore more at at kaamvaam.com

🔥 Skills

compliance (13) quality assurance (12) Quality Assurance (10) risk management (9) regulatory compliance (8) Regulatory Affairs (7) FDA (7) Project Management (7) Medical Device (6) Compliance (6)

📍 Locations

United States (65)
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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

Parexel

Regulatory Affairs Consultant United States
Skills & Focus: Regulatory Affairs, Consulting, Medical Device, Drug, Labeling, Compliance, FDA, Clinical, Regulatory Lead, CRO
Type: Remote

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

Parexel

Vice President, Technical - Medical Device United States
Skills & Focus: Regulatory Affairs, Consulting, Medical Device, Clinical, Technical, Senior Consultant, FSP, Temporary, Remote, Labeling Operations
Regulatory Affairs Jobs United States
Skills & Focus: Regulatory Affairs, Consulting, Medical Device, Drug & Device Expert, Labeling Operations, Home Based, Functional Service Provider, Senior Regulatory Affairs Associate, East Coast, Remote

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

Veeva Systems

Engagement Manager - Life Sciences Quality United States
Skills & Focus: Engagement Management, Quality Consulting, Life Sciences, Project Management, Business Development, Consulting Experience, Client Relationship Management, Pharmaceutical, MedTech, Leadership
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 of consulting experience in an established strategic/management consulting organization
Salary: $85,000 - $210,000
Type: Full-time
Benefits: Medical, dental, vision, and basic life insurance; Flexible PTO; Company paid holidays; Retirement programs; 1% charita…

Parexel

Various Levels Consulting Roles in Regulatory Operations and Affairs United States
Skills & Focus: Regulatory Affairs, Consulting, Medical Device, Project Management, CMC, Biologics, Clinical Research, Submissions, Drug Development, Talent Pool
About the Company: Parexel is a leading global biopharmaceutical services organization that provides a wide range of services to pharmaceutical, biotechnology, and medical device…
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…

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.

L3harris Technologies

Sr. Associate, Quality Analyst United States
Skills & Focus: quality, analyst, documentation, data analysis, inspection, compliance, discrepancies, hardware, process monitoring, dashboards

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

Stryker

Senior Staff Biostatistician United States
Skills & Focus: biostatistics, clinical trials, SAS programming, statistical analysis, regulatory submissions, data analysis, medical devices, clinical evidence, ISO 14155, FDA guidance
About the Company: Stryker offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes.
Experience: 6+ years of experience in clinical biostatistics
Salary: $100,500.00 - $215,300.00 plus bonus eligible
Type: Full Time
Benefits: Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness …

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

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

Mcra, An Iqvia Business

Associate Director/Director, Cardiovascular Regulatory Affairs United States
Skills & Focus: regulatory submissions, regulatory strategy, cardiac electrophysiology, regulatory bodies, project management, mentoring, clinical research, healthcare compliance, quality assurance, medical device
About the Company: MCRA is a leading medical device advisory firm and clinical research organization (CRO) that integrates regulatory, clinical research, reimbursement, healthcar…
Experience: Experience in regulatory affairs, specifically in cardiac electrophysiology, as well as management experience.
Associate Director/Director, Cardiovascular Regulatory Affairs United States
Skills & Focus: regulatory submissions, regulatory strategy, cardiac electrophysiology, regulatory bodies, project management, mentoring, clinical research, healthcare compliance, quality assurance, medical device
About the Company: MCRA is a leading medical device advisory firm and clinical research organization (CRO) that integrates regulatory, clinical research, reimbursement, healthcar…
Experience: Experience in regulatory affairs, specifically in cardiac electrophysiology, as well as management experience.

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

Dane Street

QA Supervisor United States
Skills & Focus: QA, Supervisor, medical records, accuracy, inspection, healthcare, peer review, medical claims, accuracy, compliance
About the Company: A fast-paced, Inc. 500 Company with a high-performance culture, is seeking insightful forward-thinking professionals. We process over 200,000 insurance claims …
Benefits: Medical, dental, and vision coverage; voluntary life insurance options; hospital indemnity, critical illness, accident …

Natera

Director, ECD Project Lead United States
Skills & Focus: Project Lead, Early Cancer Detection, cross-functional teams, product development, risk mitigations, qualifications, clinical product development, strategic direction, requirements, compliance
About the Company: Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic t…
Experience: Minimum 5 years of experience within the biotechnology or life sciences industry. >10 years of experience preferred.
Salary: $192,200 - $240,250 USD
Benefits: Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and t…

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

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…

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…

Johnson & Johnson

Analyst, QC - CAR-T (PG24) United States
Skills & Focus: QC testing, cGMP, CAR-T products, biopharmaceutical, laboratory data, analytical testing, cell therapy, Quality Control, laboratory environment, biologics
About the Company: Johnson & Johnson is a multinational corporation that develops medical devices, pharmaceuticals, and consumer packaged goods.
Experience: Minimum of 2 years of relevant work experience
Salary: $69,500-$102,350
Type: Full-time
Benefits: Medical, dental, vision, life insurance, disability, group legal insurance, performance bonuses

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.

Sgs

Lead Certification Auditor (Quality, Sustainability and Pharma, Cosmetics, and … United States
Skills & Focus: Lead Auditor, ISO 22716, EU GMP, WHO GMP, EFfCI, EXCiPACT, ISO 15378, ISO 9001, Sustainability, SGS Certification
About the Company: SGS is the world's leading inspection, verification, testing and certification company.
Type: Full-time

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

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.

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…

Radformation

QA Manager United States
Skills & Focus: Quality Assurance, Radiation Oncology, Medical Physics, Product Testing, Regulatory Compliance, Problem Solving, Clinical Skills, Workflow Automation, Product Quality Management, Documentation
About the Company: Radformation specializes in Radiation Oncology Cancer treatment workflow automation.

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

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…

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

Hims & Hers

Sr. Manager, Launch United States
Skills & Focus: launch plans, project management, cross-functional coordination, timeline management, change management, budget management, quality assurance, regulatory compliance, continuous improvement, pharmaceutical manufacturing
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.
Experience: 7+ years in operational environments, 5+ years in leadership
Salary: $135K – $165K
Type: Full-time
Benefits: Comprehensive health benefits, unlimited PTO, equity, 401k, employee stock purchase, offsite retreats

Biomarin Pharmaceutical Inc.

Global Medical Lead - Lysosomal Storage Disorders (LSDs) United States
Skills & Focus: Global Medical Affairs, Lysosomal Storage Disorders, Medical Strategy, Clinical Development, Regulatory Documents, Evidence Package, Patient Access, Medical Engagement, Compliance, Cross-Functional Teams
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: ≥ 7 years in Medical Affairs and Clinical Development
Type: Full-time
Benefits: Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, …