The Senior Post-Market Surveillance Specialist will own and evolve Post-Market Surveillance processes across the organization, plan, execute, and continuously improve Post-Market Surveillance processes, and support Clinical Evaluation Reports throughout the product life cycle.
Requirements
- Bachelor’s degree required. Advanced degree preferred.
- Minimum of 5 years professional experience including medical/technical writing experience.
- Experience authoring, EU MDR compliant, medical device Post-Market Surveillance reports preferred.
- Detailed knowledge of relevant MDCG guidance preferred.
- Familiarity with relevant international regulatory requirements and guidance documents for medical devices, including MEDDEV 2.7/1 revision 4
- Familiarity applying research methodology and information management.
- Experience in the medical device industry, within a Quality Management System preferred
- Proficient in MS Office applications (Word and Excel) and email systems.
- Strong organizational and follow-up skills, as well as attention to detail.
- Strong English writing and communication skills
Benefits
- Medical, dental, and vision insurance
- HRA and FSA
- Short and long-term disability
- Life insurance
- Pet insurance
- PTO
- 401(k) profit-sharing with match
- Potential year-end bonuses
