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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
2mo
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Consultant, Regulatory Affairs
Greenbelt or Maitland
HybridFull Time
9+ YOE2+ Mgmt7–12 years regulatory and compliance experience in telecom, leadership/supervisory, account management, strong client service, and regulatory analysis skills.
Microsoft Office Suite, SmartSheets, Adobe Acrobat
1mo
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Regulatory Affairs Specialist
Oak Brook, Illinois, United States
$63k-$95k/yr OnsiteFull Time
2+ YOEBachelors in life sciences/engineering, 2 years regulatory affairs experience in medical device/pharma/tissue/food, working knowledge of FDA and ISO 13485, familiarity with FDA listing systems, attention to detail; PCQI/FDQI preferred.
FURLS, CDERDirect
1mo
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Regulatory Affairs Manager (11155)
Warsaw, Indiana, United States
$113k-$142k/yr RemoteFull Time
6+ YOEBachelor's in life sciences/engineering required; 6+ years regulatory affairs experience (including FDA/EU submissions); regulatory strategy, team leadership, and regulatory IT/system experience; Power BI and PowerPoint proficiency.
Power BI, Microsoft PowerPoint
2w
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Regulatory Affairs Specialist
Torrance, California, United States
OnsiteFull Time
3+ YOE3+ years medical device experience with ≥1 year in regulatory affairs; BA/S in science/engineering or equivalent; RA certification (RAC) a plus; knowledge of global regulations, QSR820, ISO 13485, IVDR; strong communication and analytical skills.
e-MDR, MDSAP
1mo
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Staff Specialist, Regulatory Affairs
Mahwah or United States
$78k-$207k/yr HybridFull Time
4+ YOEBachelor's in engineering/science, 4+ years regulatory affairs experience in regulated industry (medical device preferred). RAC and master's preferred; knowledge of 510(k)/CE pathways and experience preparing regulatory filings.
1mo
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Principal Regulatory Affairs Specialist
Eden Prairie, Minnesota, United States
$120k-$135k/yr HybridFull Time
7+ YOEBachelor's in science or engineering required; 7+ years medical device regulatory affairs experience (or 5+ with advanced degree); hands-on FDA 510(k) experience, FDA interactions, regulatory assessments, and technical writing; RAC preferred.
21 CFR Part 807, 21 CFR Part 801, 21 CFR Part 820, 21 CFR Part 830, QMSR, ISO 13485, ISO 14971, IEC 62304, IEC 60601, GUDID/UDI, EU MDR
1mo
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Senior Regulatory Affairs Specialist
Manchester, New Hampshire, United States
OnsiteFull Time
8+ YOEBachelors in life sciences or engineering required, MD/PhD preferred. Minimum 8 years regulatory affairs experience with U.S. FDA regulations; strong communication, writing, and Microsoft proficiency.
Microsoft software products
2w
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Senior Associate, Regulatory Affairs
Lake Forest, Illinois, United States
$98k-$140k/yr HybridFull Time
7+ YOEBachelor's degree in pharmacy/biology/chemistry/pharmacology/engineering required, 7+ years regulatory affairs experience in medical products, RAC preferred, strong communication, project management, and scientific reasoning.
EHR
1w
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Regulatory Affairs Specialist
Pewaukee, Wisconsin, United States
$71k-$99k/yr OnsiteFull Time
3+ YOE3+ years quality or regulatory experience, bachelor’s in regulatory/engineering or equivalent, proficiency with MS Office/ERP/eQMS, knowledge of regulatory databases, strong decision-making and communication skills.
MS Office, Microsoft Outlook, Microsoft Word, Microsoft Excel, Microsoft Visio, ERP, eQMS, EUDAMED, FDA MAUDE database
2w
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Senior Regulatory Affairs Specialist
Austin, Texas, United States
$112k-$155k/yr OnsiteFull Time
7+ YOEBachelor in engineering or life sciences,7+ years regulatory affairs experience with Class II/III devices,knowledge of global medical device regulations,submission experience (510(k),PMA,IDE),strong communication and judgment.
MS Word, Microsoft Excel, PowerPoint, Adobe
2w
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Regulatory Affairs Strategist, Globalization (eIPRRA)
Franklin Lakes, New Jersey, United States
$138k-$220k/yr OnsiteFull Time
8+ YOEBachelor's in science/engineering/technology,8+ years medical device experience with ≥5 years in regulatory affairs, RAC preferred, ability to interpret global regulatory requirements and implement registration assessments.
1mo
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Director, US Regulatory Affairs
Morristown, New Jersey, United States
HybridFull Time
6+ YOEBachelor's in science/engineering/health with 6+ years regulatory experience in biotech/pharma (or PhD/MD/PharmD with equivalent experience); eCTD submission experience; thorough FDA and global regulatory knowledge; strong project management and communication skills.
eCTD
2w
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Senior Regulatory Affairs Specialist
Austin, Texas, United States
$112k-$155k/yr OnsiteFull Time
7+ YOEBachelor’s degree in Engineering or Life Sciences,7+ years regulatory affairs experience with Class II/III medical devices,experience with US/EU/Canada submissions,knowledge of 21 CFR/ISO/IEC standards,proficiency in MS Office,excellent communication and judgment.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Adobe
1mo
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Director, Regulatory Affairs - Neurology MedTech
Washington, District of Columbia, United States
$135k-$377k/yr OnsiteFull Time
10+ YOEBachelor's in science/engineering/regulatory required (MS/PhD preferred); neurology medical device regulatory experience required; 10+ years in regulatory affairs with project/managerial experience; FDA/Notified Body/ISO 13485 familiarity; strong writing and analytical skills.
3w
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Regulatory Affairs Spec
Andover, Massachusetts, United States
$84k-$101k/yr HybridFull Time
3+ YOEBS in life sciences/engineering preferred; 3+ years regulatory medical device experience and 2+ years interacting with regulatory agencies; RAC a plus; knowledge of US and international device regulations; Microsoft application skills; strong communication.
Microsoft Excel
1mo
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Director, Regulatory Affairs
Plano, Texas, United States
OnsiteFull Time
8+ YOEBS/MS in biomedical engineering, science, or related; 8+ years progressive medical device or regulatory agency experience; deep knowledge of FDA and global regulatory requirements, QMS and standards; leadership and communication skills; 10–20% travel.
3mo
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Principal Regulatory Affairs
Reno, Nevada, United States
$200k/yr OnsiteFull Time
10+ YOEBachelor's in science/engineering; 10+ years regulatory experience in medical device; 510(k)/PMA experience; RAC preferred; fluent in English.
FDA regulations, ISO 13485, ISO 14971, Regulatory submissions
2w
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Sr. Engineer, Regulatory Affairs and Certification, Vehicle Safety
Washington or Ann Arbor
HybridFull Time
5+ YOEFour-year automotive engineering degree or equivalent, 5+ years automotive development experience, competence in safety regulatory and certification domains, Microsoft Office proficiency, strong research and communication skills.
Microsoft Office
2w
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Director of Regulatory Affairs
Medina or Brunswick Hills Township
HybridFull Time
10+ YOE10+ years managing product stewardship/regulatory affairs for manufacturing in global markets; bachelor’s in chemistry/environmental/chemical engineering preferred; up to 25% travel; strong knowledge of US, Canada, Europe, UK, and APAC chemical regulations.
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