Key skills
Risk Management
About this role
Role Overview
- Conduct comprehensive evaluations of safety information from various channels
- Support patient safety by contributing insights to risk management and evaluations
- Assist in delivering safety perspectives for new product introductions and clinical studies
- Collaborate to provide safety inputs for regulatory submissions and compliance
- Conduct literature reviews and identify emerging safety issues
- Answer safety-related inquiries from healthcare professionals and stakeholders
- Implement safety-related policies and programs
Requirements
- 5+ years of experience with Bachelor’s OR minimum 3+ years of experience with Master’s in Medical/Clinical affairs
- Experience with Image Guided Therapy Devices preferred
- Experience as a clinician is required
- 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
Benefits
- PTO
- 401k (up to 7% match)
- HSA (with company contribution)
- Stock purchase plan
- Education reimbursement