Manager, Post Market Surveillance (Medical Devices)

Location: Gainesville, FL, United States. Workplace type: Onsite.

Company

Develops orthopedic implants and instruments focused on improving surgical experiences, mobility, and patient outcomes.

What you will do

• Lead the post-market quality team responsible for receiving, documenting, investigating, resolving, and trending customer complaints.
• Oversee medical device adverse event and incident reporting in accordance with federal and international regulations.
• Escalate and facilitate product corrections and removals, including recalls, market withdrawals, and stock retrievals.
• Communicate with the FDA, international regulatory agencies, distributors, sales representatives, and internal departments.
• Train employees, sales personnel, representatives, and customers on complaint handling, adverse event reporting, corrections and removals, and corrective and preventive actions.
• Lead or participate in regulatory and quality management system audits, and maintain systems for analyzing and trending post-market data.

Requirements

• Bachelor’s degree in a related field from an accredited institution.
• At least 7 years of experience in global medical device quality management systems.
• At least 7 years of experience with global adverse event reporting requirements.
• Previous supervisory or management experience.
• Experience with complaint trending and trend analysis, technical writing, and Windows-based word processing and spreadsheet tools.
• Knowledge of applicable federal and international medical device standards and quality system requirements.

Nice to have

• Extensive medical device post-market surveillance experience or qualifications supporting medical judgments.
• Orthopedic device industry experience.
• Familiarity with quality management software such as TrackWise or SmartSolve.

Culture & Benefits

• Work within the Quality department and report to the Director of PMS and Clinical Affairs.
• Focus on innovation in orthopedic implants, instruments, surgical technology, and patient outcomes.

Hiring process

• Initial interview.
• Hiring manager and team interviews.
• Final selection followed by an offer.