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FDA regulations Remote Jobs

48 fresh jobs found

Associate Director, Regulatory Affairs Advertising and Promotion
US - WA - offsite, Estados Unidos

Gilead Sciences

Promotional Review Labeling Therapies Commercial Strategy FDA regulations Regulatory Submissions Regulatory Affairs Vision Dental +19

USD 165K+

Senior Manager - Biocompatibility and Toxicology (Remote)
Minnesota, Virtual Address, United States

ISO 10993 Laboratory analysis Quality system procedures Biocompatibility Mitigation Strategies Toxicology Manufacturing processes Cleaning FDA regulations +26

Senior Full Time

USD 129K+

Senior Regulatory Affairs Scientist
USA - Remote, United States

Scientific Guidance IVDR Clinical Testing MDR Diagnostic Tools ISO 13485 FDA regulations Biochemistry Statistical methods +20

Senior Full Time

USD 120K+

Software Quality Assurance Engineer
Remote - Texas, United States

Solventum Remote-first

C language Medical device software Gap Assessments Software configuration management IEC 62304 Software Configuration Software Quality Assurance ISO 14971 Task Management +29

Senior Mid Full Time

USD 95K+

Manager, Quality Systems & Compliance - Purchasing Controls - Remote
USA - New Jersey - Rahway, United States

Medical device standards Supplier Audits Purchasing controls Deviations Document management systems Quality Risk Management QMS EU MDR Current good manufacturing practices +66

USD 94K+

Sr./Director, Regulatory Affairs
Virtual US

Cleerly Remote-first

FDA Submissions CE marking Slides Docs Regulatory strategy Sheets Drive Gmail FDA regulations +30

Senior Full Time

USD 210K+

Manager GD Auditing (GVP)
Remote - United States, United States

EU Regulations GVP FDA regulations Pharmacovigilance Standard Operating Procedures Drug Development FDA Auditing Quality Assurance +5

Exec Senior Full Time

USD 113K+

Advisor/Senior Advisor - Regulatory Compliance and Post Market Reporting
US: USA Remote, United States

Eli Lilly and Company

Product Shortage Management Post Market Reporting Global Regulatory Reporting Inspection Readiness FDA regulations Volunteerism GMP Philanthropy Regulatory Affairs +21

Senior Full Time

USD 121K+

Senior Regulatory Affairs Specialist
US Remote, United States

ISO 9000 GMP Compliance ISO Standards Medical Writing FDA regulations Neuromodulation Medical Technology Regulatory Submissions Healthcare systems +14

Senior Full Time

USD 115K+

Associate FDA Counsel, Advertising & Promotion
New York, NY or Remote

FTC regulations Telehealth knowledge Advertising compliance FDA regulations Legal research Telehealth Writing Research Healthcare +6

USD 116K+

Sr Systems Engineer (Remote/Flexible)
US - California (San Diego - Office), United States

Insulet Corporation

Hazards and risk assessments Cloud-based products Concept generation Enterprise system performance Performance models Grey box testing Design Trade-off HTTP protocols Non-functional requirements +37

Senior Mid Full Time

USD 109K+

Product Security Risk Analyst (Remote)
Michigan, Virtual Address, United States

IEC 81001-5-1 UL-2900 GRC platforms Nist rmf EU MDR OneTrust Medical Device Regulations Product Lifecycle Product Security +34

Entry Mid Full Time

USD 100K+

Director, Hight Tech Sourcing
Waukesha, United States

EHS regulations New product introduction Market Expertise Cross-Functional Team Management Product lifecycle management FDA regulations Strategic Relationships Supplier Management Electronics +29

Exec Senior Full Time

USD 152K+

Senior Embedded Software Engineer- Algorithm (Remote/Flexible)
US - Massachusetts, United States

Insulet Corporation

Bluetooth Low Energy TI Numerical Techniques EEPROM Wireless Protocols Flash ST USB SPI +26

Senior Full Time

USD 124K+

Director, Clinical Operations (Medical Affairs)
Remote (United States)

Revolution Medicines

Vendor governance Evidence Gathering ICH Guidelines FDA regulations Drug Development Clinical operations Smartsheet Medical Affairs Risk mitigation +13

Exec Senior Full Time

USD 204K+

Senior Counsel, Healthcare
Remote

Healthcare Fraud Marketing compliance Healthcare law CMS guidelines Legal counsel Government Affairs CAP FDA regulations CLIA +20

Senior Full Time

USD 240K+

Medical Science Liaison - Sleep, Pacific Northwest (Remote)
US - Home-Based - WA, United States

Jazz Pharmaceuticals

FDA approved products Sleep medicine Peer coaching Scientific Exchange FDA regulations Neuroscience Neurology Medical Science Liaison Scientific communication +11

USD 154K+

Senior Engineer, iOS (Hybrid/Flexible)
US - California, United States

Insulet Corporation

Design Assurance Bluetooth HIPAA regulations BLE OAuth 2.0 FDA regulations Mobile applications Diabetes Swift +17

Senior Full Time

USD 137K+

Staff Software Engineer - Full Stack Backend Focused
Austin, Texas, United States; Remote, United States

HeartFlow, Inc.

Web security Healthcare innovation Flask Django FDA regulations Vue.js Authentication Authorization Angular +23

Senior Full Time

USD 146K+

Sr. Manager, Software Engineering (Mobile)
San Diego, California, United States

Tandem Diabetes Care

Good Documentation Practices Diabetes technology Algorithm Development FDA regulations Diabetes Diabetes Care Mobile Development Swift Android +25

Senior Full Time

USD 200K+

Director Medical Science Liaison, IgG4 Rare Disease- West Territory - AZ, CO, OR, TX, WA
US - Arizona - Phoenix - Field/Remote, United States

Phoenix Personnel management Compliance Guidelines Matrix Environment FDA regulations Regulatory Guidelines Medical Science Liaison FDA Inflammation +45

Exec Senior Full Time

USD 235K+

Marketing Manager (Pharmaceutical Experience Required)
Remote - US, United States

American Regent, Inc.

Pharmaceutical marketing Creative development FDA regulations Social media management Public Relations Copywriting Microsoft Office Suite Digital Marketing Budget management +9

Senior Mid Full Time

USD 115K+

Clinical Trial Manager
Mountain View, California, United States; Remote, United States

HeartFlow, Inc.

Healthcare innovation Protocol Development ICH Guidelines FDA regulations Medical device Clinical Research Vendor Management Regulatory Compliance English +14

Senior Mid Full Time

USD 85K+

Chief Medical Safety Officer; VP, Clinical Oversight & Innovation
Remote US

Clinical Innovation Medical oversight Cardiac monitoring Clinical Oversight Scientific Leadership Scientific research FDA regulations Workflow Regulatory Submissions +24

Exec Senior Full Time

USD 287K+

Sr. Quality Manager - Global Post Market Surveillance and Complaint Handling
USA-WI-Neenah, United States

Complaint handling ISO 13485 FDA regulations Product Launch Data Reporting Health Quality Management Supply chain Risk Assessment +11

Senior Full Time

USD 158K+

Director, R&D Quality
Remote

ISO Standards Quality Management Systems FDA regulations Screening Regulatory Affairs Regulatory standards Validation Data-driven Risk mitigation +24

Exec Senior Full Time

USD 180K+

Clinical Product Surveillance Specialist
REMOTE- Illinois, United States

Medline Industries, LP

Product use Clinical workflow Medical device reporting MDR Adverse event reporting FDA regulations Cross-functional Teamwork Risk Analysis FDA +12

USD 79K+

Executive Director, US Field Medical Affairs, Health Systems Oncology
USA - Pennsylvania - North Wales (Upper Gwynedd), United States

Access strategy Tactical implementation Scientific insights Field execution MD Succession Planning Healthcare Delivery PharmD Health Systems +70

Exec Senior Full Time

USD 250K+

Marketing Manager (Pharmaceutical Experience Required)
Remote - NY, United States

American Regent, Inc.

Pharmaceutical marketing Creative development FDA regulations Social media management Public Relations Copywriting Microsoft Office Suite Digital Marketing Budget management +9

Senior Mid Full Time

USD 115K+

Director, Site Quality (Ohio)
New Albany, Ohio

Pharmaceutical Standards USP Standards Fulfillment Employee Development FDA regulations Screening Investigations Policy Development Pharmacy +20

Exec Senior Full Time

USD 180K+

Director, Site Quality (Arizona)
Gilbert, Arizona

Pharmaceutical Regulations Compounding Standards Fulfillment Employee Development FDA regulations Screening Investigations Policy Development Pharmacy +20

Exec Senior Full Time

USD 180K+

Regional Medical Scientific Director | Cardiopulmonary & Pulmonary Hypertension - GA, FL & Charleston, SC (Remote)
USA - Pennsylvania - North Wales (Upper Gwynedd), United States

Pulmonary Hypertension Data Generation Translational science Scientific Discussions Research Support GCP guidelines Inclusive culture Scientific Knowledge MD +63

Exec Senior Full Time

USD 187K+

Research Study Activation Coordinator
Remote Position, United States

American Oncology Network

Study activation Research management systems FDA regulations EMR Clinical Research Regulatory Compliance GCP Process Improvement Microsoft Office +6

USD 57K+

Associate Director, Field Medical Affairs-Hematology (southern CA/Hawaii)
Remote - United States, United States

Pharma regulations Strategic conversation B-cell malignancies OIG guidelines KOL Engagement Medical Strategy FDA regulations Strategic communication Clinical Data +10

Senior Mid Full Time

USD 173K+

Associate Director, Field Medical Affairs-Hematology (Florida)
Remote - United States, United States

B-cell malignancies Strategic conversation Pharma regulations OIG guidelines Investigator-initiated studies Medical Strategy FDA regulations Clinical Data Medical Science Liaison +8

Senior Mid Full Time

USD 173K+

Quality Assurance Auditor
REMOTE- Wisconsin, United States

Medline Industries, LP

MDD Sterilization processes Method validation MDSAP ISO Standards Process Validation MDR CAPA Quality Management Systems +16

USD 72K+

Specialist , Quality Compliance - BD Advanced Patient Monitoring
USA-California-Remote, United States

Edwards Lifesciences

Medical device reporting Human anatomy knowledge Complaint handling ISO Standards Good Documentation Practices FDA regulations Regulatory reporting ISO FDA +14

Senior Mid Full Time

USD 65K+

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

EMEA Regulations International regulatory requirements Lung cancer Pharmaceutical Product Development Patient reported outcomes Basic Science Research Clinical trial data Good clinical practices Observational Research +45

Exec Mid Full Time

USD 256K+

Senior Editor
Remote - NY, United States

Grammar and punctuation Style guide maintenance Editorial quality control AI in Healthcare Copy Editing Fact-Checking Medical Writing FDA regulations Healthcare industry +15

Senior Full Time

USD 87K+

Clinical Study Assistant
Armonk, United States

International conference for harmonization Code of federal regulations Good Clinical Practice FDA regulations ICH Guidelines Clinical Trial Management ICH SOPS Standard Operating Procedures +15

Entry Full Time

USD 66K+

Associate Director, Regulatory Affairs Advertising and Promotion
US - MD - offsite, Estados Unidos

Gilead Sciences

Promotional Review Labeling FDA regulations Strategic Guidance Commercial Strategy Regulatory Submissions Regulatory Affairs Therapies Vision +20

Senior Mid Full Time

USD 165K+

Executive Director, U.S. Regulatory Hematology Lead
Remote (US), United States

Regulatory Documentation People development Drug development process Regulatory strategy Issue management Labeling Strategic development Lifecycle Management FDA regulations +48

Senior Full Time

USD 226K+

Executive Medical Director, Early Development, Oncology
US - California - Thousand Oaks - Field/Remote, United States

Scientific method International regulatory requirements Study Management Regulatory Strategies ADAPT Peer-reviewed publications Basic Science Research Biopharmaceuticals Good clinical practices +44

Exec Senior Full Time

USD 335K+

Clinical Research Medical Director - Obesity/Cardiovascular, US - Remote
US - California - Thousand Oaks - Field/Remote, United States

EMEA Regulations International regulatory requirements Pharmaceutical Product Development Metabolic Patient reported outcomes Basic Science Research Metabolic diseases Clinical trial data Good clinical practices +51

Exec Mid Full Time

USD 256K+

Editor
Remote - NY, United States

Editorial quality control Style guide adherence Copy Editing Fact-Checking FDA regulations Medical Writing Communications Data Mentoring +8

USD 75K+

Test Engineer - West Coast (Remote)
US - California (San Diego - Office), United States

Insulet Corporation

Software hazard analysis Software metrics Peer reviews Software tool validation Test plan execution White-box Testing IEC 62304 Requirements traceability Black box testing +23

Senior Mid Full Time

USD 118K+

Project Manager, PMO/IT
Remote - United States, United States

Integer Holdings Corporation

PMO Processes Communication plans Issues management Quality Management Systems FDA regulations Resource Planning Cross-functional Team Leadership KPI Tracking Agile methodologies +5

Senior Mid Full Time

USD 108K+

Scientist, Quality Systems
United States Remote Office, United States

Health Canada Cleaning Validation IT Platform Solutions Technical Quality Issues TGA EMEA Regulations WHO Audit Response Quality Systems +22

Senior Mid Full Time

USD 66K+

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