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FDA regulations Remote Jobs

36 fresh jobs found

Product Counsel
Remote

Healthcare privacy laws Contract redlining Privacy issues Trademarks Copyrights Consumer privacy laws Legal advice FDA regulations Intellectual property +3

Senior Mid Full Time

USD 145K+

Senior Counsel, Product & Privacy – Global
US Remote

Compliance strategy Privacy training Privacy Law FDA regulations CCPA Neuromodulation Medical Technology Healthcare systems Policy Development +16

Senior Full Time

USD 151K+

Accounts Payable Technician & Process Analyst
Remote - United States

Integer Holdings Corporation

Jaggaer Esker Process Analysis Quality Management Systems Software implementation FDA regulations Accounts Payable KPI development System Integration +7

USD 59K+

Senior Clinical Research Associate
Remote, USA

PROCEPT BioRobotics

Clinical Trial Management FDA regulations Coverage Regulatory Submissions Quality Management Clinical trials Clinical Research Regulatory Compliance Data Management +10

Senior Full Time

USD 96K+

Principal Supplier Quality Engineer
USA-CT

Quality Compliance Test Method Validation Supplier Quality Engineering Project Strategy Root-cause investigation Healthcare Access CAPA Risk Evaluation Quality Engineering +13

Senior Full Time

USD 171K+

Sr. Regulatory Counsel, Healthcare
Remote

Transactional support False Claims Act Stark law Anti-kickback statute Healthcare law CMS guidelines Legal counsel CAP CLIA +18

Senior Full Time

USD 210K+

Principal GCP Quality Assurance Auditor
Remote, United States

Precision for Medicine

Electronic Clinical Trial Systems CAPA Data sciences Laboratory expertise ICH Guidelines FDA regulations Precision Medicine Self-Motivation ICH +27

Senior Full Time

USD 102K+

Principal GCP Quality Assurance Auditor
Remote, United States

Precision Medicine Group

Vendor Audits Investigator Site Audits Electronic Clinical Trial Systems CAPA Internal Audits Laboratory expertise Data sciences ICH Guidelines FDA regulations +36

Senior Full Time

USD 102K+

Supply Chain Director (Hybrid Remote)
Rockville, MD

Forecasting Tools Lean Methodologies Supplier Relationship Management KPI Monitoring GMP FDA regulations Supply chain management Operational Efficiency Inventory Management +14

Exec Senior Full Time

USD 140K+

Regulatory Analyst, Population Health & Interoperability
Remote - US

Altera Digital Health Remote-first

Cures Act Interoperability regulations Interoperability standards Population health management Altera Opal DbMotion Health IT Solutions TouchWorks Value-based care +20

USD 60K+

Senior Quality Specialist - Remote - Invitae
USA - CA - San Francisco - 1400 16th Street

ISO 820 Quality training NYSDOH ISO 15189 ISO 13485 CAP Lean Six Sigma CLIA FDA regulations +10

Senior Full Time

USD 95K+

Safety Specialist II
Remote, United States

Precision for Medicine

Meddra EMA regulations WHO drug Safety database Argus safety database Safety reporting Laboratory expertise Data sciences ICH Guidelines +23

Senior Mid Full Time

USD 72K+

Safety Specialist II
Remote, United States

Precision Medicine Group

Argus safety database Meddra WHO drug EMA regulations Safety database Safety reporting Laboratory expertise Data sciences ICH Guidelines +28

Senior Mid Full Time

USD 72K+

Software Engineer - Frontend
Austin, Texas, United States; Remote, United States

HeartFlow, Inc.

UI/UX Collaboration Healthcare innovation Web application development Web security Vue.js FDA regulations Code Quality API Integration Creative Problem Solving +23

USD 91K+

Program Manager, Engineering
Remote - United States

Integer Holdings Corporation

Oracle ERP Quality Management Systems FDA regulations Revenue Recognition Cost Management Program Management Product Development Risk Management Process Improvement +4

USD 98K+

Device Development Associate Principal Scientist (Associate Director Equivalent) – Development Strategy, Design Controls and Risk Management
USA - New Jersey - Rahway

EN 62366 Human factors guidance Quality system regulation Design Controls Medical device development Device development Design verification CGMP Design control +55

Senior Mid Full Time

USD 135K+

Senior Manager, Regulatory Diagnostics
Remote (US)

ECTD CTD Regulatory Documentation Regulatory Guidance Protocols Regulatory strategy ICH Guidelines Regulatory knowledge Adobe Acrobat +31

Senior Full Time

USD 135K+

US Director, Payor & Access Strategy Lead, Medical Affairs - Health Systems
USA - Pennsylvania - North Wales (Upper Gwynedd)

Healthcare delivery policy Pharmaco-economics Access strategy Value-Based Payment Clinical Medicine Scientific insights Population health management PharmD Scientific Acumen +55

Senior Full Time

USD 181K+

Device Development Scientist - Development Strategy, Design Controls and Risk Management
USA - New Jersey - Rahway

Medical device development Quality system regulation Human factors guidance Design Controls Device development Design control Design verification CGMP Regulatory Submission +50

USD 83K+

Director, Regulatory Affairs, Advertising/Promotion
Remote (US)

Commercial Compliance Promotional Materials Review Patient Safety Scientific Communications Healthcare Compliance Regulatory strategy Labeling Strategic Guidance Veeva Vault +36

Exec Senior Full Time

USD 166K+

VP, Chief Medical Safety Officer
Remote US

Medical Safety Scientific Leadership Clinical Oversight FDA regulations Workflow Regulatory Submissions Electrophysiology Regulatory Affairs Cardiology +13

Exec Senior Full Time

USD 287K+

U.S. Regulatory Affairs Senior Manager
US - California - Thousand Oaks - Field/Remote

Product Labeling Legislation Awareness Regulatory policy Global Regulatory Strategy Regulatory research Regulatory Documents Regulatory Guidance Regulatory strategy Labeling +26

Senior Full Time

USD 139K+

Executive Director, Regulatory Advertising and Promotions (Remote)
Remote (United States)

PTC Therapeutics, Inc.

Labeling Claims Promotional Materials FDA regulations Veeva Pharmaceutical Industry Regulatory Affairs Biotechnology Pharmaceutical Regulatory Compliance +6

Exec Senior Full Time

USD 242K+

Partenaire de l’activation des Centres Cliniques I ou II // Site Activation Partner I or II
CAN - QC - Remote

Good Clinical Practice (GCP) Quality review Good clinical practices FDA regulations Document management ICH Project Coordination Pharmaceutical Industry FDA +14

CAD 60K+

Sr. Regulatory Manager
Remote

Software as a medical device ISO 15189 CAP ISO 14971 ISO 13485 Quality Management Systems FDA regulations CLIA Genomics +17

Senior Full Time

USD 145K+

Regulatory Affairs Specialist
US Field Non-Sales (Remote Workforce)

Health software 21 CFR 801 Non-medical software 510k Medical software 21 CFR 820 EU MDR Medical device industry Product Lifecycle +16

USD 65K+

Clinical Research Medical Director - Cardiology/Heart Failure, US - Remote
US - California - Thousand Oaks - Field/Remote

Cardiovascular disease EMEA regulations Basic Science Research Clinical trial data Pharmaceutical Product Development International regulatory requirements Regulatory Interactions Metabolic Patient reported outcomes +42

Exec Mid Full Time

USD 256K+

Quality Engineer
USA - CA - Remote

Human Factor Engineering Process Validation Design control ISO 14971 ISO 13485 Health benefits Quality Management Systems Quality Engineering Change Control +26

USD 77K+

Senior Manager Regulatory Strategy - Remote Opportunity
Deerfield, IL, US

Marketing Applications Cross-Functional Team Collaboration Regulatory strategy Documentation Management FDA regulations Clinical Studies Biologics Strategy Development FDA +10

Senior Full Time

USD 125K+

Senior Regulatory Affairs Specialist
US Remote

QSR experience GMP Compliance ISO 9000 Acrobat ISO Standards FDA regulations Medical Technology AutoCAD Regulatory Submissions +12

Senior Full Time

USD 100K+

Senior Manager Regulatory Strategy - Remote Opportunity
Deerfield, Illinois, US

Marketing Applications Cross-Functional Team Collaboration Regulatory strategy Documentation Management FDA regulations Clinical Studies FDA Biologics Strategy Development +10

Senior Full Time

USD 125K+

Clinical Research Medical Director – Endocrinology/Obesity , US - Remote
US - California - Thousand Oaks - Field/Remote

EMEA regulations Basic Science Research International regulatory requirements Clinical trial data Pharmaceutical Product Development Observational Research Publications Metabolic Regulatory Interactions +43

Exec Mid Full Time

USD 256K+

Clinical Research Medical Director, Oncology
US - California - Thousand Oaks - Field/Remote

EMEA regulations Basic Science Research Lung cancer International regulatory requirements Clinical trial data Pharmaceutical Product Development Observational Research Medical Monitoring Publications +41

Exec Mid Full Time

USD 256K+

FDA Regulatory Lawyer
US - US - Remote

Alcohol compliance Packaging and labeling Product safety Consumer protection Consumer protection laws FDA regulations Due Diligence Regulations Regulatory Compliance +3

Senior Full Time

USD 175K+

Staff Front-End Engineer
Austin, Texas, United States; Remote, United States

HeartFlow, Inc.

Healthcare innovation Web application development FDA regulations Front-end development Code Quality Vue.js UI/UX Design API Integration Web applications +23

Senior Full Time

USD 146K+

Quality Lead/ Lead Validation Engineer - 5122
Boston, Massachusetts, United States - Remote

Computerized Systems MHRA Regulations ISPE guidelines Good Documentation Practice GAMP 5 Risk-based approach ISO Standards Quality Management Systems GxP +11

Senior Contract Full Time

USD 87K+

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