2,150 regulatory jobs at 731 companies in Massachusetts
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Regulatory Coordinator
Boston, Massachusetts, United States
$22-$27/hrOnsiteFull Time
Tufts Medicine: Integrated academic health system providing clinical care and medical research.
Bachelor’s degree required; one year of research-related experience preferred. Requires regulatory knowledge, organization, attention to detail, computer skills, and strong communication abilities.
Institutional Review Board (IRB), HIPAA, Electronic Medical Records (EMR)
Director, Regulatory Strategy – Global Regulatory Lead
Boston, Massachusetts, United States
$212k-$259k/yrHybridFull Time
Beeline Medicines: A clinical-stage biotechnology focused on precision therapies for autoimmune diseases.
10+ YOE5+ MgmtAdvanced life sciences degree; 10+ years regulatory affairs; global regulatory leadership; experience with FDA/EMA; immunology/autoimmune knowledge.
Akebia TherapeuticsNasdaq: AKBA: Developing innovative therapeutics for patients with kidney disease.
10+ YOE10+ years pharmaceutical/biotech regulatory labeling experience, bachelor’s in a scientific field, deep FDA/EMA knowledge, leadership experience, ability to translate regulatory frameworks and lead cross-functional teams.
SanofiEuronext Paris: SAN: Researches, develops, and manufactures medicines and vaccines globally.
6+ YOEBS/BA in a scientific discipline required; advanced degree preferred. Minimum 6 years pharma/biotech experience with ≥4 years regulatory affairs; experience preparing IND/CTA, (s)BLA/(s)NDA/MAA, HA briefing documents and leading submissions preferred.
New York City or Boston or San Francisco or Salt Lake City or Milton Park or Montréal or London
$208k-$281k/yrRemoteFull Time
RecursionNASDAQ: RXRX: Developing medicines using an AI-native drug discovery platform.
10+ YOE10+ years pharma experience with 8+ years in global regulatory affairs; experience with major health authorities and regulatory submissions; strong regulatory strategy, communication, and cross-functional collaboration skills.
Merck KGaA, Darmstadt, GermanyFrankfurt Stock Exchange: MRK: A science and technology in healthcare, life sciences, and electronics.
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.
Merck KGaAFrankfurt Stock Exchange: MRK: Develops pharmaceutical, life science, and electronics technologies.
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.
5+ YOEAdvanced scientific degree preferred, significant regulatory affairs experience (senior level), proven global regulatory strategy and HA engagement, strong communication and cross-functional leadership skills.
Helen of TroyNASDAQ: HELE: Designs and markets branded consumer housewares and personal care products.
4+ YOEBachelor's degree in a relevant field, 4+ years regulatory medical device experience, authorized to work in the US, knowledge of ISO 13485/9001, experience with 510(k) submissions, and proficiency with Microsoft Office.
Microsoft Office, Microsoft Excel, Microsoft Word, Microsoft PowerPoint
San Mateo or New York City or Boston or Salt Lake City
HybridFull Time
Overjet: AI platform for dental diagnostics and practice management.
7+ YOERequires 7+ years in medical device regulatory affairs, 2+ years with FDA software as a medical device, global submissions experience, regulatory framework expertise, and a scientific or engineering bachelor's degree.
FDA 510(k), De Novo, Health Canada Medical Device License (MDL), EU MDR, UK MHRA, Australian TGA, 21 CFR Part 820, Software as a Medical Device (SaMD), ISO 13485, ISO 14971, IEC 62304, ISO 27001, HIPAA, GDPR
Austin or California or Colorado or Illinois or Massachusetts or Mississippi or Nebraska or New Jersey or New York or North Carolina or Pennsylvania or Texas or Utah or Washington
$105k-$140k/yrHybridFull Time
Aceable: Providing accredited mobile courses for professional licensing and certification.
8+ YOE8+ years regulatory/compliance experience; managing multi-state approvals, researching and interpreting regulations, preparing submissions, designing scalable processes, mentoring staff, strong communication, and experience with automation/AI tools.
Bristol Myers SquibbNew York Stock Exchange: BMY: Develops and distributes innovative medicines for serious diseases.
4+ YOEAdvanced scientific degree preferred, 4+ years regulatory affairs experience, proven global regulatory strategy and HA engagement, leadership of cross-functional teams, strong written/verbal communication and negotiation skills.
Gaithersburg or South San Francisco or Santa Clara or Cambridge
$109k-$164k/yrOnsiteFull Time
AstraZenecaLondon Stock Exchange: AZN: Researches and develops medicines to treat major diseases globally.
3+ YOEBachelor's in a scientific/regulatory discipline, 3+ years regulatory experience in biopharma or health authority, strong project management and leadership skills, knowledge of drug development, excellent communication.
Johnson & JohnsonNYSE: JNJ: Develops and manufactures pharmaceutical drugs and medical devices.
6+ YOEBachelor's degree or equivalent,6+ years regulatory experience in medical devices,knowledge of US/EU regulations,RAC preferred,ability to lead teams and interact with regulatory agencies,travel up to 10%.
Verily: Developing data-driven technologies for clinical research and precision health.
5+ YOEBachelors in a quantitative field and 5+ years regulatory affairs experience in medical device/digital health; expertise in SaMD/AI/ML compliance, FDA guidance, ISO 13485, risk management, and statistical evaluation; proficiency with Jira, GitHub, and Google Workspace.
Jira, GitHub, Google Workspace, document control systems, Python, R, Claude, ChatGPT
Oberdorf or Zuchwil or Raynham or West Chester or Palm Beach Gardens
HybridFull Time
Johnson & JohnsonNYSE: JNJ: Provides pharmaceutical products and medical technology healthcare solutions.
6+ YOEBachelor's degree,6+ years regulatory experience in medical devices,knowledge of US/EU medical device regulations,RAC preferred,ability to travel up to 10%,team leadership and regulatory submission experience.
Genetix Biotherapeutics: Developing and commercializing curative gene therapies for rare diseases.
10+ YOE10+ years biopharma CMC regulatory experience for biologics/gene therapies; bachelor’s or master’s in life sciences; experience with post-approval CMC submissions, GMP and global regulatory frameworks; strong communication and cross-functional skills.
DrägerXETRA: DRW3: Manufacturer of medical and safety technology products worldwide.
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.
Tri-Imaging Solutions: Provider of medical imaging parts, repair, and technical training.
3+ YOEBachelor's in Food Science (Master's preferred),3+ years food manufacturing/regulatory/QA experience,2+ years managing labeling and regulatory documentation,leadership experience,knowledge of FDA/USDA/HACCP/SQF,Microsoft Office and ERP proficiency.