2mo
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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.
1mo
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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
2mo
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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
2mo
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Head of Exploratory and Regulatory Safety Sciences
Boston, Massachusetts, United States
$280k-$420k/yr HybridFull Time
15+ YOEPhD or DVM; 15+ years preclinical safety experience; regulatory strategy leadership; expertise in preclinical development for small molecules and biologics; strong regulatory knowledge (FDA, EMA, ICH) and GLP compliance.
GLP, FDA, ICH, EMA, Regulatory Guidelines
3d
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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
1mo
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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)
2mo
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Staff Quality Engineer
Braintree, Massachusetts, United States
$109k-$150k/yr OnsiteFull Time
8+ YOEBachelor’s degree in engineering or related field with 8+ years in quality engineering in regulated medical device/life sciences environments; experience with ISO 13485, ISO 14971, FDA QSR; strong background in FMEA, CAPA, and quality system procedures.
DFMEA, PFMEA, DoE, SPC, Quality Management System, ISO 13485, ISO 14971, FDA QSR
1mo
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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.
3w
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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
2mo
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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
2mo
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Associate Director, Clinical Quality Assurance
Waltham, Massachusetts, United States
$155k-$190k/yr HybridFull Time
10+ YOE10+ years in FDA-regulated industry; hands-on with Veeva; QA leadership; regulatory knowledge; strong communication and collaboration.
Veeva Quality Docs, Veeva Training, Veeva QMS, Microsoft Word, PowerPoint, Excel, Adobe, SharePoint
2mo
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Director, US Advertising and Promotional Compliance
Boston, Massachusetts, United States
$193k-$290k/yr HybridFull Time
7+ YOE1+ MgmtOversees US advertising/promotional compliance; regulatory affairs leadership; FDA liaison; develop/promote compliant promo processes.
2mo
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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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Clinical Trial Associate, Clinical Operations, Infectious Disease
Cambridge, Massachusetts, United States
$74k-$118k/yr HybridFull Time
2+ YOE2+ years clinical research experience, bachelor's in science preferred, familiarity with FDA and ICH GCP, strong communication, organizational skills, and attention to detail.
EDC, IWRS, ePRO, eTMF
2mo
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MDI Mechanic - 3rd Shift
Fall River, Massachusetts, United States
$20-$24/hr OnsiteFull Time
2+ YOEPackaging mechanic with 2-4 years of packaging experience; high school diploma or GED; knowledge of cGMP and FDA regulations; able to communicate in English.
Machinery maintenance, Process equipment
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.
1mo
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Associate Director, Global Regulatory Lead, Oncology
Boston or Cambridge
$154k-$243k/yr HybridFull Time
6+ YOELead global regulatory strategies for oncology programs, oversee major submissions, manage FDA interactions, collaborate cross-functionally, and mentor regulatory teams.
1w
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Director/ Senior Director, Regulatory CMC
Boston, Massachusetts, United States
$200k-$265k/yr OnsiteFull Time
8+ YOEDoctorate preferred; ≥8 years Regulatory CMC biologics experience with FDA sCDER interactions, global submissions, lifecycle management, and biologics/combination product development.
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