599 fda jobs at 244 companies in Malden, MA
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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
1mo
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Regional Regulatory Manager
Billerica, Massachusetts, United States
$104k-$156k/yr HybridFull Time
1+ YOEAdvanced degree such as PhD, PharmD, or MD; at least 1 year of US drug development regulatory strategy experience; FDA interaction experience and matrix leadership skills.
FDA
1w
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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
5d
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Quality & Compliance Manager
New Britain or Exeter or Seabrook
OnsiteFull Time
5+ YOERequires 5+ years in senior medical device or pharmaceutical quality assurance, FDA or Notified Body inspection experience, people management, advanced Microsoft Office, and fluent English.
Microsoft Office, FDA, ISO 13485
1mo
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Regional Regulatory Manager
Billerica, Massachusetts, United States
$104k-$156k/yr HybridFull Time
1+ YOEAdvanced degree such as PhD, PharmD, or MD; at least 1 year of US drug development regulatory strategy experience; FDA interaction experience; and demonstrated matrix leadership skills.
FDA
2d
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Associate Director, Clinical Quality Compliance
Bedford, Massachusetts, United States
$192k-$215k/yr HybridFull Time
8+ YOEBS/BA, MS, or PhD with 8+ years in biotech, pharma, or CRO; knowledge of FDA, EU, and ICH GCP/GCLP regulations; auditing, risk management, communication, and collaboration skills.
TANGO, FDA, EMA, ICH, CRO, CAPA, TMF, ESPP
2d
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Compliance Specialist
Bedford, New Hampshire, United States
OnsiteFull Time
2+ YOERequires 2+ years in GMP, ISO, or FDA-regulated environments, quality-system technical writing, cGMP investigations, root-cause and risk analysis; science or engineering bachelor's preferred.
GMP, ISO, FDA, CAPA, SOP
1d
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System Engineer I
Pleasanton or Atlanta or Burlington
$74k-$116k/yr OnsiteFull Time
Bachelor’s degree in engineering, computer science, or related discipline. Preferred: medical product development experience, systems engineering expertise, and knowledge of ISO, FDA design controls, and risk management.
mobile applications, cloud-based web applications, RF, electromagnetics, ASICs, Bluetooth, NFC, ISO, FDA
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
1w
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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)
1w
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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
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
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
1w
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Senior Director, Product Development
Methuen, Massachusetts, United States
OnsiteFull Time
7+ YOEBachelor's degree with 10+ years or master's degree with 7+ years of experience; technical regulated-industry experience, product introduction, design controls, lifecycle management, project management, and FDA regulatory knowledge required.
Windows, Microsoft Office, E-mail, Microsoft Project, FDA 21 CFR, 510(k), IEC 60601, 62304, 62366
2mo
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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)
5d
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Sr. Regulatory Affairs Specialist
Burlington, Massachusetts, United States
$98k-$122k/yr HybridFull Time
5+ YOEBachelor's degree and 5+ years of regulatory affairs experience required, including medical device submissions. Requires FDA regulatory knowledge, electronic submissions expertise, communication skills, and Microsoft Word and Adobe Acrobat proficiency.
Microsoft Word, Adobe Acrobat, FDA, ISO, CFR
2d
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Sr. Manager, Corporate Quality - GCP
Bedford, Massachusetts, United States
$136k-$170k/yr HybridFull Time
8+ YOEBS/BA in a scientific discipline and 8+ years in a related industry, including 6+ years in Clinical Quality Assurance, clinical trial teams, audits, GCP, ICH, FDA, EU requirements, and Quality Management Systems.
GCP, FDA, ICH, CAPA, GxP, Quality Management System
2mo
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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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