Senior Post Market Surveillance Specialist

Johnson & Johnson · Cincinnati, OH

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SafetyFull-time$79k–$128kCompany career page

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Role summary

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.

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 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

What you'll be doing

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

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