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FDA regulations Remote Jobs

40 fresh jobs found

US Director, Senior Payer & Access Strategy Lead, Medical Affairs, Health Systems Oncology (Remote)
USA - Pennsylvania - North Wales (Upper Gwynedd), United States

Field Execution Pharmaco-economics Ethical Guidelines Scientific insights Pharmacoeconomics Clinical Medicine Access strategy MD PharmD +56

Senior Full Time

USD 206K+

Electronic Clinical Outcomes Assessments (eCOA) Technical Specialist
US - California - Thousand Oaks - Field/Remote, United States

ECOA EDC Good clinical practices CTMS FDA regulations FDA Inflammation Rare Disease Therapeutic Areas +31

USD 130K+

Software Engineer, iOS (Remote/Flexible)
US - Massachusetts, United States

Insulet Corporation

Bluetooth Design Assurance BLE Objective-C HIPAA regulations OAuth 2.0 Agile software development FDA regulations Diabetes +25

USD 102K+

Quality Assurance Auditor
REMOTE- Illinois, United States

Medline Industries, LP

MDSAP MDD Sterilization processes Sterilization Method validation Process Validation MDR ISO Standards Follow-up +22

USD 79K+

Clinical Trials Lawyer
US - US - Remote

GCPs Clinical trial agreements Negotiating agreements Legal negotiation Legal Experience ICH Guidelines Contract drafting FDA regulations Legal advice +11

USD 115K+

US Scientific Director, Medical Affairs - Cardiovascular & Metabolism (Remote)
USA - Pennsylvania - North Wales (Upper Gwynedd), United States

Field Execution Insights Analysis Congress planning Metabolism Scientific Training Scientific insights Scientific Excellence Scientific Acumen Research Experience +50

Exec Senior Full Time

USD 187K+

Clinical Research Medical Director - Hematology Oncology
US - Maryland - Baltimore -Field/Remote, United States

EMEA guidelines Pharmaceutical Product Development International regulatory requirements Basic Science Research Lung cancer Regulatory Interactions Medical Monitoring Observational Research Patient reported outcomes +46

Exec Mid Full Time

USD 261K+

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

Insulet Corporation

Design Assurance Bluetooth BLE Medical device software HIPAA regulations OAuth 2.0 FDA regulations Mobile applications Software architecture +20

Senior Full Time

USD 124K+

Senior Software Engineer, Cloud (Remote / Flexible)
US - California, United States

Insulet Corporation

Gang of Four MSK Cloud architectural patterns Springboot Design Assurance SOLID Medical device software HIPAA regulations Insulin Pumps +39

Senior Full Time

USD 130K+

Senior Software Engineer, Cloud (Remote / Flexible)
US - California (San Diego - Office), United States

Insulet Corporation

Gang of Four MSK Cloud architectural patterns Springboot Design Assurance SOLID Medical device software HIPAA regulations Insulin Pumps +38

Senior Full Time

USD 130K+

Principal Regulatory Affairs Specialist/Engineer (SaMD)
Virtual US

Cleerly Remote-first

De novo requests CE marking 510k FDA Submissions Sheets Regulatory strategy ISO 14971 Drive FDA regulations +32

Senior Full Time

USD 179K+

Senior Director, Head of Veterinarian Medicine
Remote - US, United States

American Regent, Inc.

Good Clinical Practice FDA regulations Animal Health Pharmacovigilance Cross-functional Teamwork Veterinary Medicine Clinical Studies Medical Affairs Vendor Management +7

Senior Full Time

USD 240K+

Clinical Database Specialist (Remote/Flexible)
US - Massachusetts, United States

Insulet Corporation

ISO regulations Data management plan Query generation MS Windows applications Data trends EDC Systems Case Report Forms Electronic Data Capture Data documentation +16

USD 101K+

Associate Vice President – Global Development, Immunology
US: USA Remote, United States

Eli Lilly and Company

Medical expertise Data Dissemination Medical research Clinical trial data Clinical Strategy Good clinical practices Clinical Pharmacology Patient Safety Protocol Development +49

Senior Mid Full Time

USD 252K+

Senior Software Engineer - Full Stack (Remote/Flexible)
US - Massachusetts, United States

Insulet Corporation

Browserify SOLID Medical device software Node js HIPAA regulations React JS Bamboo NPM CSS3 +38

Senior Full Time

USD 124K+

Sr. Quality System Specialist (Remote/Flexible)
US - Massachusetts, United States

Insulet Corporation

Quality system regulation Traceability Document Control ISO 14971 QMS Quality Management Systems ISO 13485 FDA regulations ISO +25

Senior Mid Full Time

USD 89K+

Sr. Director, Global Logistics and Supplier Controls (Remote, US)
Lansing, MI, US

ISO Standards Medical Device Regulations Audit Management FDA regulations ISO 13485 Customer requirements Supplier Management Quality Management Logistics +10

Senior Full Time

USD 200K+

Director – S+N Service Operating System – Service Eco-system, CRM & Digital Solutions ( Remote - US)
US - Field, United States

Enterprise Digital Solutions Financial Data Modeling API Strategy CSA Middleware integration ServiceMax Lean management CSV System integrations +20

Exec Senior Full Time

USD 160K+

Sr Quality Assurance Auditor
REMOTE- Illinois, United States

Medline Industries, LP

Sterilization processes MDD MDSAP Sterilization Method validation MDR Process Validation ISO Standards Follow-up +24

Senior Mid Full Time

USD 96K+

Biostatistician III
New York City, NY

Time-to-event analysis Statistical strategy Survival analysis Real-world data analysis Real-world data Experimental Design Epidemiology FDA regulations Real-World Evidence +25

Senior Mid Full Time

USD 115K+

Biostatistician III
Chicago, IL, NYC, NY, Redwood City, CA, Boston, MA

Time-to-event analysis Statistical strategy Survival analysis Real-world data Experimental Design Epidemiology FDA regulations Real-World Evidence Clinical Care +24

Senior Mid Full Time

USD 100K+

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

Pharmaceutical Product Development EMEA Regulations International regulatory requirements Basic Science Research Regulatory Interactions Patient reported outcomes Observational Research Clinical trial data Scientific Presentations +44

Exec Mid Full Time

USD 261K+

Specialist, Analytical Research
USA - New Jersey - Rahway, United States

MDR Regulations GMP Testing Stability testing Method validation Combination product development Technical Report Writing Good manufacturing practice Design verification Drug delivery +51

USD 94K+

Senior Specialist, Analytical Research
USA - New Jersey - Rahway, United States

MDR Regulations GMP Testing Method validation Combination product development Design verification Device development Drug delivery ISO Standards Analytical support +60

Senior Mid Full Time

USD 104K+

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+

Executive Medical Director, Global Development Lead
US - California - Thousand Oaks - Field/Remote, United States

Health Authority Queries Drug commercialization Disease biology International regulatory requirements Scientific method Basic Science Research Regulatory Interactions Leadership Attributes ADAPT +55

Senior Full Time

USD 342K+

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+

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+

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 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+

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 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+

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+

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