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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in medical product safety surveillance, including risk assessment and safety signal identification, while providing insights for regulatory submissions and health hazard evaluations. Strong communication skills are essential for influencing cross-functional stakeholders and supporting safety policies and procedures.
Highest-signal resume keywords
Medical Product Safety SurveillanceHealth Hazard EvaluationsRisk-Benefit AnalysesISO and IEC RegulationsCertified Professional in Patient Safety (CPPS)
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Post-Marketing Surveillance AnalysisClinical Trial Data AnalysisReal-World Evidence Data AnalysisSafety Signal IdentificationRegulatory Submission Support
Soft Skills
Excellent CommunicationInfluencing Stakeholders
Certifications & Qualifications
Certified Professional in Patient Safety (CPPS)
Industry Keywords
Medical Device IndustryClinical AffairsMedical SafetyHealth Hazard EvaluationsRisk-Benefit Analyses
About the role
Key responsibilities & impact- Independently oversee medical product safety surveillance activities
- Analyze post-marketing surveillance, literature review, clinical trial, and real-world evidence data
- Identify and assess potential risks and safety signals
- Provide safety insights and recommendations for Health Hazard Evaluations, Risk-Benefit Analyses, and recall procedures
- Support New Product Introduction, clinical studies, and post-marketing efforts
- Provide safety input for regulatory submissions, RBAs, protocols, Clinical Study Reports, and Clinical Evaluation Reports
- Respond to safety-related inquiries from healthcare professionals, patients, and internal stakeholders
- Support implementation of safety policies, procedures, and programs
- Monitor evolving medical product safety regulations and guidelines
- Contribute to safety studies and vigilance activities throughout the product lifecycle
- Work in a field-based role
Requirements
What you’ll need- 5+ years of experience with a bachelor’s degree, or 3+ years of experience with a master’s degree or higher, in Medical/Clinical Affairs/Medical Safety in the Medical Device industry
- Bachelor’s/master’s degree or higher in Medical Science, Nursing or equivalent
- Strong knowledge of relevant medical device industry standards and regulations, including ISO and IEC
- Strong knowledge of Health Hazard Evaluations, Issue Impact Assessments, and Risk-Benefit Analyses in a medical device environment
- Prior bedside-related clinical experience preferred
- MD/PhD preferred
- Related specialized clinical experience preferred
- Certified Professional in Patient Safety (CPPS) preferred
- Excellent communication and ability to influence cross-functional stakeholders
- Must successfully perform minimum physical, cognitive, and environmental job requirements with or without accommodation
- US work authorization required; visa sponsorship unavailable
- Must reside in or within commuting distance to posted locations
Benefits
Comp & perks- Generous PTO
- 401k with up to 7% match
- HSA with company contribution
- Stock purchase plan
- Education reimbursement
- Annual incentive bonus may be offered
- Sales commission may be offered
- Long-term incentives may be offered
