Senior Post-Market Surveillance Specialist

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