Senior Post Market Surveillance Specialist (MedTech)

Location: Cincinnati, Ohio, United States; hybrid work with a minimum of 3 days on site per week

Salary: $79,000–$127,650 base pay per year

Company

Johnson & Johnson MedTech develops smarter, less invasive, and personalized medical treatments through the intersection of biology and technology.

What you will do

• Manage daily workflows for assigned medical device complaint records.
• Communicate with Service, Sales, and other internal teams to gather complaint and event details.
• Determine complaint reportability and submit applicable reports to the FDA and other regulatory agencies.
• Perform good-faith efforts to obtain returned products and required information for assessments.
• Review investigation documentation, complaint records, response letters, and required record completion.
• Support post-market data reporting, complaint investigations, lab operations, equipment management, and internal and external audits.

Requirements

• Bachelor’s degree in life science, engineering, or a similar field, or an equivalent combination of education and experience.
• 3+ years of experience in a commercial medical device company, preferably in Quality, including 2+ years in complaint handling.
• Familiarity with US FDA regulations 21 CFR Parts 803, 806, and 820, EU Medical Device Regulations, and ISO 13485.
• Ability to work in a regulated environment and manage multiple activities while prioritizing tasks effectively.
• Strong written and verbal communication, teamwork, and cross-functional collaboration skills.
• Must be based in Cincinnati, Ohio, and able to work on site at least 3 days per week.

Nice to have

• Experience with audit management, quality control, quality management systems, compliance management, and continuous improvement.
• Knowledge of ISO 9001, standard operating procedures, issue escalation, and fact-based decision-making.

Culture & Benefits

• Full-time employment with Johnson & Johnson MedTech.
• Hybrid work through the J&J Flex program.
• Retirement pension and 401(k) savings plans.
• Vacation, sick time, holiday pay, parental, bereavement, caregiver, volunteer, and military spouse leave may be available under applicable plans and policies.
• Relocation assistance is not available.