Medical Device Regulatory Affairs – Clinical Evaluation Manager
Global Regulatory Writing & Consulting (GLOBAL)
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $125,000 - $150,000 per year
About the role
- Responsible for the end-to-end planning, execution, and delivery of medical device regulatory writing projects across global regulatory frameworks.
- Focus on EU MDR Clinical Evaluation (including CERs).
- Support premarket regulatory submissions in either the United States (e.g., 510(k), De Novo, PMA) and/or EU MDR Technical Documentation.
- Oversee complex documentation programs (e.g., CERs, PMCF, SSCPs, Technical Documentation, and premarket submission dossiers) and/or manage large client portfolios across multiple products and regulatory jurisdictions.
- Provide leadership and operational oversight to a team of Medtech Medical Writers, ensuring high-quality, compliant, and timely deliverables.
- Directing, delegating, and reviewing work; establishing clear project expectations; maintaining accountability for performance against timelines, budgets, and quality standards.
- Interpret and operationalize regulatory requirements into executable project plans and writing strategies.
- Drive continuous improvement of templates, processes, and workflows to enhance efficiency, scalability, and quality.
- Contribute to business development activities, including marketing, proposal development, scoping, and client onboarding.
Requirements
- Master’s degree or higher in a scientific, medical, or engineering discipline preferred.
- 5+ years of experience in medical device regulatory writing, with demonstrated EU MDR expertise.
- Demonstrated experience authoring Clinical Evaluation Reports (CERs).
- Experience supporting FDA premarket submissions (510(k), De Novo, and/or PMA), including authoring and/or strategy OR Experience authoring and/or leading EU MDR Technical Documentation (Annex II/III) and broader MDR submission strategy.
- Strong working knowledge of: EU MDR, MEDDEV 2.7/1 Rev 4, and applicable MDCG guidance.
- FDA device regulatory framework.
- Experience managing complex projects and/or leading teams in a consulting or regulatory environment.
- Demonstrated experience conducting comprehensive literature reviews, data appraisal, and state-of-the-art analyses.
- Experience interacting with Notified Bodies and/or FDA and preparing responses to regulatory questions strongly preferred.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory writingClinical Evaluation Reports (CERs)premarket submissionsEU MDR Technical Documentationproject managementliterature reviewsdata appraisalregulatory strategydocumentation programscompliance standards
Soft Skills
leadershipoperational oversightdelegationaccountabilitycontinuous improvementcommunicationteam managementclient onboardingmarketingproposal development
Certifications
Master’s degreescientific disciplinemedical disciplineengineering discipline