1,444 regulatory affairs jobs at 788 companies in United States
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Senior Regulatory Affairs Specialist
San Diego, California, United States
$91k-$152k/yr HybridFull Time
5+ YOE5+ years regulatory affairs experience for medical devices, proficiency with US and EU device regulations, experience supporting 510(k)/license/technical documentation submissions, strong technical writing and communication.
4w
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Sr Regulatory Affairs Specialist- Medical Devices
Schaumburg, Illinois, United States
$93k-$144k/yr OnsiteFull Time
3+ YOE3+ years regulatory/quality experience in US and Canada medical devices; authored a 510(k); Health Canada licensing experience; BS in science or related; strong writing and regulatory system skills.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, GUDID, UDI, US FDA electronic system
2mo
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Regulatory Affairs Specialist
Huntersville, North Carolina, United States
OnsiteFull Time
3+ YOEBachelor’s degree; at least 3 years regulatory affairs experience in medical devices or pharma; strong knowledge of domestic/global regulations; RAC a plus.
Microsoft Office Suite, Regulatory software
3mo
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Principal Regulatory Affairs
Reno, Nevada, United States
$200k/yr OnsiteFull Time
10+ YOEBachelor's in science/engineering required,10+ years medical device experience with ≥6 years in regulatory affairs,experience with 510(k) and PMA,knowledge of FDA and ISO regulations,RAC preferred.
2mo
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Director, Regulatory Affairs
Jersey City, New Jersey, United States
$213k-$233k/yr HybridFull Time
10+ YOE10+ years regulatory affairs experience; FDA and international regulatory knowledge; clinical regulatory content and submissions; strong communication; individual contributor.
eCTD, Regulatory submissions
3mo
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Senior Associate, Regulatory Affairs
Philadelphia or San Francisco
OnsiteFull Time
2+ YOEBachelor’s in life sciences; 2+ years Regulatory Affairs in biotech/pharma; oncology/IND experience; strong communication; regulatory submissions; FDA/ICH knowledge.
2mo
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Manager, Regulatory Affairs
Waltham, Massachusetts, United States
$116k-$160k/yr RemoteFull Time
Deciphera Pharmaceuticals: Developing targeted kinase inhibitors for the treatment of cancer.
6+ YOE6+ years pharma experience; 4+ years Regulatory Affairs; knowledge of regulatory requirements; strong communication; ability to manage multiple priorities.
2mo
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Regulatory Affairs Director
United States
$150k-$175k/yr RemoteFull Time
4+ YOERegulatory affairs director with 4+ years medical device experience; manage submissions, registrations, listings; maintain regulatory files; support audits and labeling.
MS Office, Databases, Online research
4w
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Director, Regulatory Affairs
New York City or Boston or San Francisco or Salt Lake City or Milton Park or Montréal or London
$208k-$281k/yr RemoteFull Time
10+ YOE10+ years pharma experience with 8+ years in global regulatory affairs; experience with major health authorities and regulatory submissions; strong regulatory strategy, communication, and cross-functional collaboration skills.
1mo
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Regulatory Affairs Manager
Santa Ana, California, United States
$38-$48/hr OnsitePart Time
5+ YOEBachelor's in a scientific field, 5+ years regulatory affairs experience in dietary supplements/botanicals/TCM, PCQI required, HACCP preferred, audit and FDA regulatory experience.
1d
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Regulatory Affairs Manager
Austin, Texas, United States
RemoteFull Time
5+ YOEBachelor's degree and 5+ years in health insurance regulatory affairs or compliance; requires regulatory research, filings, insurance law knowledge, SERFF, and strong analytical and communication skills.
System for Electronic Rate and Form Filing (SERFF)
2mo
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Manager, Regulatory Affairs
Santa Monica or Foster City or El Segundo or Thousand Oaks
$133k-$172k/yr HybridFull Time
5+ YOEBS +7 years or MS +5 years regulatory affairs experience; in-depth knowledge of ICH and regional regulatory requirements; experience preparing regulatory submissions, labeling and packaging input; strong communication and organizational skills.
3mo
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Director, Regulatory Affairs
Durham, North Carolina, United States
OnsiteFull Time
10+ YOEMS or advanced degree; 10+ years in drug regulatory affairs; FDA interactions; submissions; leadership and cross-functional collaboration.
eCTD, Regulatory Submissions, Publishing
1mo
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Regulatory Affairs Specialist
Bloomingdale, Illinois, United States
$50k-$60k/yr OnsiteFull Time
Experience in regulatory affairs for medical devices, bachelor's degree in related field (master's preferred), knowledge of FDA and EU MDR, ISO 13485, regulatory submissions, documentation, and audit readiness.
2mo
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Director, Regulatory Affairs
South San Francisco, California, United States
$225k-$263k/yr HybridFull Time
7+ YOE10+ years of drug development, 7+ years in regulatory affairs; biotech/pharma; cardiovascular focus; Bachelor's required; advanced degree preferred; strong global regulatory and eCTD experience.
eCTD, Regulatory_submissions
1mo
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Regulatory Affairs Manager
United States
$120k-$150k/yr RemoteFull Time
5+ YOEBachelor's degree, 5+ years regulatory affairs/compliance experience, ability to travel 15-25%, valid US work authorization and driver's license, leadership and regulatory interpretation skills.
Microsoft Office
2mo
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Regulatory Affairs Specialist
Logan, Utah, United States
OnsiteFull Time
2+ YOERegulatory affairs specialist with 2-5 years in medical devices, FDA/EU MDR/ISO 13485, submissions, strong communication.
FDA Regulations, 21 CFR Part 820, EU MDR, ISO 13485, MDSAP, eSTAR, EUDAMED
2w
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Regulatory Affairs Specialist
Owings Mills, Maryland, United States
OnsiteFull Time
3+ YOE3+ years medical device regulatory experience preparing EU MDR technical documentation, CERs, PMS/PMCF, and international submissions; bachelor\u0002s degree in life sciences/engineering/regulatory affairs; strong regulatory writing and project management.
Microsoft Excel, Microsoft Outlook, Microsoft PowerPoint, Microsoft Word, Microsoft Teams
1w
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Director, Regulatory Affairs
Somerset, New Jersey, United States
$194k-$254k/yr HybridFull Time
7+ YOERequires PharmD, PhD, or equivalent science/healthcare degree; 7+ years in regulatory affairs and IND, CTA, BLA, or MAA submissions; global regulatory strategy, biologics, and cell therapy experience preferred.
IND, CTA, BLA, MAA, FDA, E-Verify, Form I-9, TCR-T, NK
1mo
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Regulatory Affairs Director
Gaithersburg, Maryland, United States
$179k-$268k/yr HybridFull Time
3+ YOEBachelor's in a science field with ≥3 years regulatory strategy experience, knowledge of regulatory affairs across development stages, experience with major health authority interactions, strong strategic thinking and communication skills.
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