Senior Post Market Surveillance Specialist
Johnson & Johnson · Cincinnati, OH
QualityFull-time$94k–$152kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Senior Post Market Surveillance Specialist responsible for managing domestic and international product surveillance activities for medical devices at Johnson & Johnson's MedTech division. The role involves complaint handling, regulatory reporting, and cross-functional collaboration to ensure compliance with FDA and international regulations.
What they're looking for
- Bachelor's degree in Life Science, Engineering, or equivalent education and experience
- 3+ years commercial medical device company experience, preferably in Quality
- 2+ years of complaint handling experience
- Knowledge of 21 CFR Part 803, 806, 820, EU Medical Device Regulations, and ISO 13485
- Strong written and verbal communication skills
- Ability to manage multiple priorities and work effectively in regulated environments
- Demonstrated teamwork and cross-functional collaboration skills
What you'll be doing
- Manage daily complaint record workflows and coordinate with Service and Sales teams
- Assess complaint reportability and submit regulatory reports to FDA and other agencies
- Conduct good faith efforts for product returns and gather information for complaint evaluation
- Review investigation and complaint records for completeness and compliance
- Ensure timely customer complaint response letters and support audit activities
Privacy & handoff
This role links to Johnson & Johnson's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.