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Medical Safety Manager
PhilipsMedical Safety Manager in the Medical Device/Biotech field conducting safety assessments and providing support for compliance and transparency in evaluations. Collaborating across teams to identify and mitigate potential risks.
Core Competencies
Role fitCore Competencies
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Demonstrates extensive experience in Medical Affairs within the Medical Device and Biotech industries, with a strong focus on Risk Management, Health Hazard Evaluations, and compliance with industry standards. Proficient in analyzing safety data and providing insights for regulatory submissions and clinical studies.
Highest-signal resume keywords
7+ Years Experience In Medical AffairsActive Clinical License (Nursing Or MD)Knowledge Of Health Hazard EvaluationsRisk-Benefit Analysis ExpertiseFamiliarity With ISO And IEC Standards
ATS Keywords
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Hard Skills
Risk ManagementHealth Hazard EvaluationsRisk-Benefit AnalysisSafety Data AnalysisClinical Trial EvaluationPost-Marketing SurveillanceLiterature ReviewRegulatory ComplianceMedical Device VigilanceIssue Impact Assessment
Certifications & Qualifications
Active Clinical License
Industry Keywords
Medical DeviceBiotechClinical AffairsSafety Information EvaluationNew Product IntroductionRegulatory SubmissionsEmerging Safety IssuesSafety Studies
About the role
Key responsibilities & impact- conduct comprehensive evaluations of safety information sourced from a variety of channels
- provide support in Risk Management, Health Hazard Evaluations, Risk-Benefit analyses, and recall procedures
- assist in delivering safety-related perspectives for New Product Introduction projects, clinical studies and Post-Marketing Surveillance efforts
- collaborate to provide safety inputs for regulatory submissions, ensuring compliance and transparency
- conduct literature reviews and surveillance activities to identify emerging safety issues
- provide input into safety studies and medical device vigilance activities
- analyze safety data from clinical trials and post-market surveillance
Requirements
What you’ll need- 7+ years of experience in Medical/Clinical affairs in Medical Device/Biotech industry or equivalent
- active clinical license (Nursing or MD strongly preferred)
- strong knowledge of relevant standards and regulations for the medical device industry (ISO, IEC, etc.)
- strong knowledge and understanding of Health Hazard Evaluations, Issue Impact Assessments, and Risk-Benefit Analyses
- Bachelor’s/master’s degree in medical, Nursing, or equivalent (MD preferred)
- must be able to perform the minimum Physical, Cognitive and Environmental job requirements
Benefits
Comp & perks- generous PTO
- 401k (up to 7% match)
- HSA (with company contribution)
- stock purchase plan
- education reimbursement