Job Description

Senior Post Market Surveillance Specialist position at Johnson & Johnson's MedTech division in Cincinnati, Ohio. Responsible for managing domestic and international product surveillance activities, complaint handling, and regulatory reporting for medical devices. Reports to Senior Manager of Post Market Surveillance.

Responsibilities

• Manage daily workflows for assigned complaint records and determine reportability
• Submit applicable regulatory reports to FDA and other regulatory agencies
• Communicate with Service, Sales, and internal teams to identify complaint details and event specifics
• Review investigation and complaint records for completeness and ensure timely customer responses
• Perform Good Faith Effort for product returns and support complaint investigations

Requirements

• Bachelor's degree in Life Science, Engineering, or equivalent education and experience
• 3+ years commercial medical device company experience, preferably in Quality
• 2+ years complaint handling experience
• Knowledge of FDA regulations (21 CFR Parts 803, 806, 820), EU Medical Device Regulations, ISO 13485
• Strong written and verbal communication skills
• Ability to manage multiple activities simultaneously and prioritize effectively
• Experience working in regulated environments compliant with ISO 13485 and 21 CFR 820

Compensation: $79,000.00 - $127,650.00 base

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