We are seeking a Staff Clinical Evaluation Specialist to collaborate with cross-functional teams to ensure the successful preparation of high-quality clinical documents for global market availability. The role involves leading the development, authoring, and revision of clinical and regulatory documentation, including clinical evaluations, post-market surveillance, and clinical studies.
Requirements
- Bachelor of Science degree in a health- or science-related discipline
- Minimum of 4+ years of industry experience in clinical, quality, or regulatory affairs
- At least 3 years of direct experience authoring clinical evaluations for medical devices
- Demonstrated experience analyzing clinical, post-market, and preclinical data in accordance with global regulatory requirements
Benefits
- Health insurance
- Dental insurance
- Vision insurance
- Life insurance
- 401(k) matching
- Retirement plan
- Paid time off
- Sick leave
- Vacation days