134 regulatory specialist jobs at 91 companies in Woonsocket, RI
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Senior Regulatory Specialist
Marlborough, Massachusetts, United States
$89k-$111k/yr HybridFull Time
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
3mo
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Regulatory Specialist
Warren, Rhode Island, United States
OnsiteFull Time
1+ YOEBachelor's degree and 1-2 years related experience; BS in Food Science or Nutritional Science preferred.
1d
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Clinical Regulatory Specialist
New York City or Cambridge or Southlake or United States or Europe or Asia or Australia
HybridFull Time
2+ YOERequires 2+ years in clinical research, regulatory affairs, or clinical operations; experience with Phase 2–4 trials, GCP, FDA requirements, IRB processes, SOPs, regulatory documents, and clinical research technology.
Clinical Trial Management System (CTMS), electronic regulatory platform, eSource
1w
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Federal Regulatory Specialist
Boston, Massachusetts, United States
$80k-$120k/yr OnsiteFull Time, Temporary
Requires federal rail regulatory compliance, FTA funding regulations, GAAP, financial and business planning, audits, reporting, regulated HR experience, and a bachelor's degree in a related field.
Generally Accepted Accounting Principles (GAAP)
2mo
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Regulatory & Clinical Specialist
Chicago or Atlanta or Austin or Denver or Houston or Phoenix or Boston or Minneapolis or Charlotte or Dallas or United States
$85k-$95k/yr RemoteFull Time
5+ YOESupport EU MDR and US regulatory submissions; develop CEP/CER; conduct literature reviews; liaison with regulatory authorities and internal teams.
Medical writing, Regulatory submissions, Literature databases
2mo
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Senior Regulatory Affairs Specialist
Marlborough or Irvine or Arden Hills or Maple Grove
$89k-$170k/yr HybridFull Time
4+ YOEBachelor’s degree in a scientific or technical discipline, 4+ years of medical-industry regulatory affairs experience, and experience with 510(k), EU MDR, or international regulatory registrations.
Microsoft Office
4w
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Senior Regulatory Affairs Specialist
Marlborough or Maple Grove
$89k-$170k/yr HybridFull Time
4+ YOEBachelor's in a scientific/technical discipline, 4+ years regulatory affairs experience in medical devices, experience with implantable/active devices, regulatory submissions and design controls, knowledge of FDA/EU regulations.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint
4w
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Senior Regulatory Affairs Specialist
Marlborough or Maple Grove
$89k-$170k/yr HybridFull Time
4+ YOEBachelor's in a scientific/technical discipline, 4+ years regulatory affairs experience in medical devices, experience with implantable/active devices, regulatory submissions and FDA/EU requirements, strong writing and cross-functional collaboration skills.
Microsoft Word, Microsoft Excel, PowerPoint
1w
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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
3w
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Regulatory Escalation Specialist Intermediate
Johnston, Rhode Island, United States
OnsiteFull Time
3+ YOEBachelor's degree in business or related field, minimum 3 years' relevant experience, strong regulatory knowledge, analytical and communication skills, ability to manage escalations and cross‑functional projects.
1mo
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Sr. Specialist, Regulatory Affairs
Burlington, Massachusetts, United States
$110k-$150k/yr OnsiteFull Time
5+ YOEBachelor's degree,5+ years medical device regulatory experience,authored 510(k)/CE documentation,knowledge of biocompatibility/sterilization/packaging/ISO standards,RAC preferred,ability to work onsite.
1d
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Sr Regulatory Affairs Specialist
Boston, Massachusetts, United States
$101k-$127k/yr HybridFull Time
3+ YOEBachelor’s degree with 3+ years’ experience or master’s degree with 1+ year; regulatory submissions experience, FDA IVD knowledge, scientific data interpretation, strong communication, collaboration, negotiation, and problem-solving skills.
FDA, Center for Devices and Radiological Health (CDRH), HIPAA
2w
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Senior Regulatory Affairs Specialist
Burlington, Massachusetts, United States
$115k-$130k/yr OnsiteFull Time
5+ YOEBachelor's in life sciences/engineering required (advanced degree preferred); 5+ years medical device regulatory experience (or 3+ with advanced degree); knowledge of US FDA and EU MDR requirements; experience with IDE/PMA submissions and Notified Body interactions.
2mo
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Regulatory Reporting & Compliance Specialist
Keene or Madison or Boston
$62k-$103k/yr HybridFull Time
5+ YOEExperience in regulatory/stat reporting, SQL/BigQuery and Microsoft Excel expertise, knowledge of state insurance laws and rate/form filings, ability to reconcile datasets, and 5+ years in regulatory compliance or insurance preferred.
SQL, BigQuery, GCP, Microsoft Excel, Jira, Microsoft PowerPoint
2w
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Regulatory Affairs Specialist II, Expansion
Boston, Massachusetts, United States
$120k-$160k/yr OnsiteFull Time
4+ YOE4+ years regulatory affairs experience for medical device or digital health, EU MDR and IEC 62304 knowledge, experience with international submissions, strong communication and project management.
1mo
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Regulatory Reporting & Compliance Specialist
Keene or Boston or Madison
$62k-$103k/yr HybridFull Time
5+ YOERequires regulatory compliance and insurance experience, knowledge of state insurance laws, SQL/BigQuery, advanced Excel, data reconciliation, process documentation, analytical skills, and cross-functional collaboration.
SQL, Google BigQuery, Microsoft Excel, Jira, Microsoft PowerPoint
3w
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Regulatory Specialist for Center for Anesthesia Research Excellence
Boston, Massachusetts, United States
$60k-$88k/yr OnsiteFull Time
1+ YOEBachelor's degree required (Master's preferred),1-3 years regulatory or clinical research experience, knowledge of FDA/NCI/OHRP guidelines, ability to maintain confidentiality, and proficiency with web-based systems and Microsoft Office.
Microsoft Outlook, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Access
1d
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Regulatory Remediation Specialist – Risk & Governance Vice President
Boston or Quincy
$120k-$203k/yr OnsiteFull Time
Regulatory remediation experience in technology, cybersecurity, risk, or governance; senior individual-contributor experience in regulated environments; strong writing, technical aptitude, organization, prioritization, and stakeholder management skills.
2mo
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Usability and Regulatory Affairs Specialist
Lincoln, Rhode Island, United States
$90k-$110k/yr OnsiteFull Time
3+ YOE3+ years in human factors/usability or regulatory affairs in medical devices; Bachelor's in biomedical engineering or related; strong technical and analytical skills; familiarity with FDA and EU MDR preferred; ability to travel ~5 trips/year.
4w
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Prin Regulatory Affairs Spec
North Haven or Mansfield or Mounds View or Boston or Lafayette
$120k-$180k/yr OnsiteFull Time
7+ YOEBachelor's degree, minimum 7 years regulatory experience (or advanced degree with 5+ years), experience with 510(k)/FDA interactions preferred, knowledge of medical device regulatory lifecycle, strong communication and cross-functional collaboration skills.
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