- Conduct comprehensive evaluations of safety information from Post-Marketing Surveillance and literature searches
- Contribute insights and recommendations to Risk Management, Health Hazard Evaluations, Risk-Benefit analyses, and recall procedures
- Provide safety perspectives for New Product Introduction projects, clinical studies, and Post-Marketing Surveillance efforts
- Supply safety inputs for regulatory submissions, Risk-Benefit Analyses, protocols, Clinical Study Reports, and Clinical Evaluation Reports
- Conduct literature reviews and surveillance activities to identify emerging safety issues
- Respond to safety-related inquiries from healthcare professionals, patients, and internal stakeholders
- Contribute to safety-related policies, procedures, and programs
- Maintain awareness of evolving medical product safety regulations and guidelines
- Provide input into safety studies and medical device vigilance activities
- Analyze clinical-trial and post-market surveillance data to identify safety signals and trends
Requirements
- 5+ years of experience with a Bachelor's OR minimum 3+ years of experience with a Master's
- Experience in Medical/Clinical Affairs in the Medical Device/Biotech industry or equivalent
- Experience with Image Guided Therapy Devices preferred
- Experience as a clinician is required
- Bachelor's/Master's Degree in Medical, Nursing, or equivalent
- MD preferred
- Strong knowledge of relevant medical device industry standards and regulations (ISO, IEC, etc.)
- Strong knowledge of Health Hazard Evaluations, Issue Impact Assessments, and Risk-Benefit Analyses in a medical device environment
- Ability to meet minimum physical, cognitive, and environmental job requirements with or without accommodation
- Excellent communication and ability to influence cross-functional stakeholders using clinical expertise and knowledge of standard of care and medical device standards
- US work authorization required
- Candidates requiring current or future work-visa sponsorship will not be considered
Core Competencies
Demonstrates expertise in conducting safety evaluations, analyzing clinical trial data, and providing insights for risk management in the medical device industry. Proficient in regulatory submissions and maintaining compliance with evolving safety regulations.
Highest-signal resume keywords
- Medical Device Industry Standards
- Health Hazard Evaluations
- Risk-Benefit Analyses
- Clinical Affairs Experience
- Image Guided Therapy Devices
Hard Skills
- Safety Evaluations
- Post-Marketing Surveillance
- Literature Reviews
- Clinical Study Reports
- Data Analysis
- Regulatory Submissions
- Risk Management
- Medical Device Vigilance
- Emerging Safety Issues
- Clinical Evaluation Reports
Soft Skills
- Excellent Communication
- Influencing Stakeholders
Certifications & Qualifications
- Bachelor's Degree in Medical or Nursing
- Master's Degree in Medical or Nursing
- MD Preferred
Industry Keywords
- Medical Device
- Biotech
- ISO Standards
- IEC Standards
- Clinical Affairs
- Safety Signals
- Risk-Benefit Analysis
- Post-Marketing Surveillance
- Health Hazard Evaluation
- Image Guided Therapy
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Medical Safety Manager – Image-Guided Therapy Devices Arbeitgeber: Jobtailor
Als Front Office Supervisor in unserem dynamischen Team bieten wir Ihnen die Möglichkeit, in einem unterstützenden und freundlichen Arbeitsumfeld zu wachsen. Wir legen großen Wert auf die berufliche Entwicklung unserer Mitarbeiter und bieten regelmäßige Schulungen sowie die Chance, Verantwortung zu übernehmen. Unsere Lage ermöglicht es Ihnen, Teil einer lebendigen Gemeinschaft zu sein, während Sie gleichzeitig die Standards unseres Franchise-Partners einhalten und unseren Gästen einen unvergesslichen Aufenthalt bieten.
