Post-Market Surveillance Manager — Medical Devices

Advita Ortho, LLC; Gainesville (FL); On-site; USD 90,000 - 130,000; Full time

Job summary

Advita Ortho, LLC is seeking a Manager, Post Market Surveillance to lead the QA Post-Market team and establish systems for surveillance and quality compliance across domestic and international regulations.

You will oversee adverse event reporting, product corrections, and communications with FDA and global agencies, ensuring training and adherence to regulatory requirements. Strong leadership and technical writing skills are essential.

Qualifications

• Bachelor’s degree required in a related field.
• Extensive background in medical device post-market surveillance or equivalent qualifications.
• Minimum 7 years’ experience in global medical device quality management systems.
• Minimum 7 years’ experience in global adverse event reporting requirements.
• Experience in complaint trending and trend analysis.
• Orthopedic device industry experience preferred.

Responsibilities

• Lead and manage the QA Post-Market team handling receipt, documentation, investigation, resolution and trending of customer complaints.
• Oversee adverse event and incident reporting compliant with federal and international regulations.
• Escalate and facilitate product corrections/removals ( recalls, withdrawals, stock retrievals ).
• Coordinate with distributors, sales force, international reps and internal teams for reporting training.
• Communicate post-market surveillance activities to FDA and international agencies; train personnel on regulatory requirements.
• Lead or participate in regulatory and QMS audits to ensure successful outcomes.
• Ensure procedures and documentation meet global compliance guidelines.
• Develop, monitor and maintain systems to analyze and trend post-market data.
• Apply Advita’s Quality System and relevant federal/international standards.

Skills

Regulatory knowledge

Post-Market Surveillance

Quality Management

Adverse Event Reporting

Leadership

Technical Writing

Regulatory Audits

TrackWise/SmartSolve

Education

Bachelor’s Degree in a related field

Tools

MS Office

TrackWise

SmartSolve

Job description

Advita Ortho, LLC is seeking a Manager, Post Market Surveillance to lead the QA Post-Market team and establish systems for surveillance and quality compliance across domestic and international regulations.

You will oversee adverse event reporting, product corrections, and communications with FDA and global agencies, ensuring training and adherence to regulatory requirements. Strong leadership and technical writing skills are essential.