387 fda jobs at 175 companies in Bristol, RI
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Staff Engineer, Design Quality (CDx/FDA)
Marlborough, Massachusetts, United States
$105k-$125k/yr HybridFull Time
8+ YOESenior design quality expert with 8+ years in medical device/IVD quality, strong regulatory and technical judgment.
2mo
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Director, Quality & Regulatory- Mergers & Acquisitions (M&A)
Colorado Springs or Nashville or Bothell or Gainesville or San Diego or Plymouth or Cambridge
$162k-$258k/yr HybridFull Time
15+ YOE15+ years in FDA-regulated medical device environments, leadership in quality/regulatory and M&A, Bachelor's required (Master's/MBA preferred), knowledge of FDA/ISO/EU MDR, QMS and KPI-driven governance.
QMS, FDA, ISO 13485, ISO 14971, EU MDR, TSLA, KPI
3mo
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Medical Physicist, R&D
Marlborough, Massachusetts, United States
$98k-$153k/yr OnsiteFull Time
3+ YOEMaster's in Medical Physics or related field; 3+ years with Master’s or PhD; familiarity with IEC/FDA standards; medical device development experience preferred.
Medical Imaging, Imaging Systems, Quality Control, IEC 60601, IEC 62366, FDA regulations
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Prin Regulatory Affairs Spec - Core Surgical innovations
Lafayette or Mansfield or Mounds View or North Haven or Boston
$120k-$180k/yr OnsiteFull Time
5+ YOEBachelor's degree and 7+ years or advanced degree and 5+ years in regulatory affairs; medical device, FDA, EU, ISO, audits, submissions, leadership, and communication experience required.
FDA, Medical Device Directive (93/42/EEC), Medical Device Regulation (EU 2017/745), ISO 14971, ISO 13485, artificial intelligence, machine learning
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Senior Director, Regulatory Advertising and Promotion
Boston, Massachusetts, United States
$211k-$316k/yr HybridFull Time
10+ YOEBachelor's degree in science or health-related discipline and 10+ years of pharmaceutical or related experience, including 7+ years reviewing advertising and promotional materials; FDA regulatory expertise required.
FDA, OPDP, APLB, CAPA, SOPs, ISI
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Staff Catheter Engineer
Waltham, Massachusetts, United States
$107k-$179k/yr OnsiteFull Time
4+ YOEBachelor's degree in engineering and 4+ years of medical device product development experience. Requires catheter design experience, SolidWorks proficiency, and Design Controls experience under FDA and ISO requirements.
SolidWorks, FDA, ISO, Design Controls, Design of Experiments (DOE), Design Failure Mode and Effects Analysis (DFMEA), Process Failure Mode and Effects Analysis (PFMEA)
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Director, Regulatory Advertising and Promotion
Boston, Massachusetts, United States
$211k-$316k/yr HybridFull Time
8+ YOEBachelor’s degree in science or health-related discipline; 8+ years pharmaceutical or related experience, including 5+ years reviewing promotional materials; FDA promotional regulations and OPDP/APLB expertise.
FDA, OPDP, APLB, CAPA
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Senior Overnight Bakery Manager - Boston Bakery
Boston, Massachusetts, United States
$95k/yr OnsiteFull Time
7+ YOE3+ Mgmt7+ years bakery manufacturing or high-volume food production; 3+ years in leadership; GMP/HACCP/OSHA/FDA knowledge; bilingual English/Spanish preferred; valid driver’s license.
GMP, HACCP, OSHA, FDA
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US Regulatory Strategy lead
Waltham, Massachusetts, United States
$185k-$210k/yr RemoteFull Time
6+ YOERequires a scientific bachelor's degree, 6+ years of regulatory affairs experience, FDA meeting leadership, major NDA/BLA application experience, strong communication, judgment, negotiation, and regulatory knowledge.
FDA, IND, NDA, BLA, sNDA, sBLA, GMP, GLP, GCP
2w
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Site Quality Assurance Engineer
Pawtucket, Rhode Island, United States
$75k-$95k/yr OnsiteFull Time
3+ YOEBS in science or engineering, 3+ years regulated environment experience (preferably medical device), strong problem-solving, familiarity with ISO 13485/14971 and FDA QSR, statistical analysis, and CAPA experience.
ISO 13485, ISO 14971, FDA QSR, GMP
1d
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Director of Regulatory Affairs
Watertown or Boston
HybridFull Time
10+ YOERequires a life sciences bachelor's degree, 10+ years of pharmaceutical regulatory experience, multinational development experience, CTD familiarity, FDA and international regulatory knowledge, leadership, communication, and project management skills.
FDA, IND, NDA, MAA, CTD
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Validation Engineer
Boston, Massachusetts, United States
OnsiteFull Time
3+ YOEBachelor's in life science, 3+ years biotech/pharma/medical device validation experience, knowledge of FDA cGMP, FMEA, CSV, protocol generation and IQ/OQ/PQ reporting, strong written/verbal communication.
FDA cGMP, FMEA, Computerized System Validation (CSV), Piping and Instrumentation Diagram (P&ID)
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Sr. Manager, R&D (Boston, MA, US)
Boston, Massachusetts, United States
$160k-$175k/yr OnsiteFull Time
8+ YOE3+ MgmtBachelor’s in engineering; 8+ years engineering experience with at least 3 years in leadership; CAD (SolidWorks) experience; knowledge of ISO 13485, FDA, ISO 14971, IEC 62366, IEC 60601; strong communication and team leadership.
SolidWorks, CAD, ISO 13485, FDA, ISO 14971, IEC 62366, IEC 60601
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Sr. Deviations Owner Specialist
Juncos or Caguas or Boston or United States or Puerto Rico or Dominican Republic or Mexico or Germany or Canada or South America
OnsiteContract
5+ YOEBachelor's in life sciences/engineering/pharmaceuticals, 5+ years deviation management/QA in FDA-regulated sterile/aseptic environments, strong GMP/FDA/regulatory knowledge, eQMS/CAPA/deviation tracking experience, analytical and communication skills.
deviation tracking systems, CAPA management, electronic quality management systems (eQMS)
1mo
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Senior Director Regulatory Affairs, US Advertising and Promotion (Billerica, Massachusetts, US, 01821)
Billerica or Boston
$258k-$388k/yr HybridFull Time
10+ YOEBachelor’s in science/health required; advanced degree preferred. 10+ years pharma/regulatory experience with ≥7 years as primary reviewer of promotional materials. Deep FDA promotional expertise, team leadership, and ability to engage cross-functionally and with FDA.
1mo
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Regulatory Coordinator II - Clinical Trial Office
Brookline or Maine or Vermont or New Hampshire or Massachusetts or Connecticut or Rhode Island
$61k-$68k/yr HybridFull Time
1+ YOECompletes regulatory submissions and tracking for clinical trials (IND/IDE, IRB, FDA), maintains regulatory files, coordinates study start-up, and ensures compliance with FDA and ICH/GCP; requires bachelor’s degree or equivalent experience and 1–3 years regulatory experience.
Microsoft applications, databases
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Sub-Investigator
Boston, Massachusetts, United States
OnsiteFull Time
Nurse Practitioner with clinical research experience; licensure in good standing; familiar with GCP/ICH and FDA regulations.
EKG, Phlebotomy, Lab testing, Nursing
3mo
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Director, Regulatory Strategy – Global Regulatory Lead
Boston, Massachusetts, United States
$212k-$259k/yr HybridFull Time
10+ YOE5+ MgmtAdvanced life sciences degree; 10+ years regulatory affairs; global regulatory leadership; experience with FDA/EMA; immunology/autoimmune knowledge.
Regulatory Strategy Tools, FDA/EMA regulatory guidance databases
1mo
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Key Account Principal Clinical Specialist
Boston or United States
$87k-$173k/yr RemoteFull Time
3+ YOEAdvanced degree, 3+ years EP industry experience, proficiency with Salesforce and PowerBI, willingness to travel 50%, ability to comply with FDA and hospital procedures.
Salesforce, PowerBI
2mo
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Executive Director, Regulatory Affairs
Waltham, Massachusetts, United States
$250k-$310k/yr OnsiteFull Time
18+ YOESenior regulatory leader with 18+ years in regulatory affairs, 10+ in management; strong FDA/EMA knowledge; CTD experience; regulatory filings leadership.