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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical evaluation and regulatory strategy for medical devices, with a strong focus on evidence synthesis, documentation, and compliance with global regulatory requirements. Proven ability to lead cross-functional teams and mentor colleagues while enhancing clinical evaluation methodologies.
Highest-signal resume keywords
Clinical Evaluation AuthoringRegulatory Submissions SupportLiterature Review ExecutionEvidence SynthesisCross-Functional Project Management
ATS Keywords
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Hard Skills
Clinical EvaluationRegulatory StrategyEvidence-Based RecommendationsSystematic Literature ReviewsPost-Market SurveillanceScientific AnalysisBenefit-Risk AssessmentClinical DocumentationMedical WritingProduct Lifecycle Management
Soft Skills
MentoringTeam LeadershipCollaborationCommunicationProcess Improvement
Certifications & Qualifications
Master of Science DegreeDoctoral Degree (Preferred)
Industry Keywords
Medical DevicesGlobal Regulatory RequirementsISOFDAHealthcare IndustryClinical AffairsQuality AssuranceMarket Access ActivitiesPost-Market Clinical Follow-UpClinical Evidence Strategies
About the role
Key responsibilities & impact- Lead the development and execution of clinical evidence strategies for new product development and lifecycle management activities
- Manage clinical evaluation projects, aligning clinical evidence, regulatory strategy, product claims, and commercialization objectives
- Author and maintain clinical evaluations, post-market clinical follow-up documentation, regulatory submissions, annual reports, and other clinical documentation
- Design and execute systematic literature reviews
- Evaluate published evidence and synthesize clinical, preclinical, and post-market data into scientifically supported conclusions
- Assess benefit-risk profiles of medical devices and develop evidence-based recommendations in accordance with global regulatory requirements
- Partner with regulatory authorities and internal stakeholders to address clinical evidence requirements and support regulatory submissions
- Develop scientific communications, including manuscripts, conference abstracts, presentations, white papers, and customer-facing evidence materials
- Mentor team members, lead cross-functional review processes, and identify opportunities to improve clinical evaluation methodologies, documentation practices, and team efficiency
Requirements
What you’ll need- Master of Science degree in a health, clinical, biological science, biomedical, engineering, or related scientific field
- Minimum 6 years of experience in clinical affairs, regulatory affairs, quality, medical writing, clinical evaluation, post-market surveillance, or related field
- Minimum 2 years of experience authoring clinical evaluations for medical devices
- Experience conducting literature reviews, evidence synthesis, and scientific analysis using clinical and/or technical data
- Experience supporting regulatory submissions and product lifecycle activities within a regulated healthcare industry
- Preferred: Doctoral degree (PhD, PharmD, MD, or equivalent) in a health or science-related discipline
- Preferred: Experience supporting global medical device regulatory requirements, including clinical evaluation, post-market clinical follow up, and market access activities
- Preferred: Experience applying global regulatory requirements, including ISO, FDA, and international regulations
- Preferred: Experience managing complex cross-functional projects within the medical device industry
Benefits
Comp & perks- Remote position within the United States
- Travel percentage: None
- Equal opportunity employment
- Pay transparency and compensation discussion protections