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
1w
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Senior Software Quality Engineer
Manchester, New Hampshire, United States
OnsiteFull Time
5+ YOEMS or BS in Engineering/Computer Science,5+ years in FDA-regulated industry,knowledge of FDA QSMR,ISO62304,GAMP5,experience in requirements management,ability to write procedures,proficiency with Microsoft Office.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Visio, FDA QSMR, ISO62304, GAMP5
1w
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Product Cybersecurity Engineer (Medical Devices)
Wilmington, Massachusetts, United States
$135k-$202k/yr OnsiteFull Time
7+ YOE7+ years cybersecurity/product security experience supporting FDA-regulated medical devices or SaMD, Master's degree (Ph.D preferred), threat modeling, vulnerability management, and familiarity with FDA guidance and cybersecurity frameworks.
STRIDE, NIST Cybersecurity Framework, ISO 14971, IEC 62304, AAMI TIR57, OWASP, SBOM
2w
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Senior Regulatory Specialists
Billerica, Massachusetts, United States
HybridFull Time
4+ YOEBachelor's in life science, minimum 4 years IVD/medical device regulatory experience, knowledge of FDA/IVDR/ISO standards, experience with FDA and CE registrations, ability to prepare submissions and review labeling.
Simoa, PhenoCycler, PhenoImager Fusion, PhenoCode Panels
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.
2w
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Principal Software Applications Engineer Onsite in Burlington MA
Burlington, Massachusetts, United States
$158k-$197k/yr OnsiteFull Time
Knowledge of FDA, ISO, and GMP; experience with risk assessments, validation/verification, troubleshooting manufacturing issues, and design transfer documentation.
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
2mo
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Clinical Data Manager
Burlington or Redwood City
$145k-$160k/yr HybridFull Time
5+ YOE5+ years in clinical data management in pharma/biotech; Medidata Rave; knowledge of GCP, FDA/EMA, CDISC; strong communication and teamwork.
Medidata Rave, SAS, Electronic Data Capture (EDC)
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