Manager, Post Market Surveillance

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

Manager, Post Market Surveillance

Department: Quality

Employment Type: Full Time

Location: Gainesville, FL

Reporting To: Director, PMS and Clinical Affairs

Description

The purpose of the Manager QA for Post Market is to provide leadership as the designated function for managing and establishing the necessary Medical Device Post-Market Surveillance and Quality System requirements to ensure compliance to all applicable domestic and international regulations.

Key Responsibilities

• Lead and manage the QA Post-Market Team that is responsible for the receipt, documentation, investigation, resolution, and trending of customer complaints to ensure regulatory compliance and customer satisfaction
• Oversees the team responsible for determining and processing medical device adverse event and incident reporting requirements compliant with federal and international regulations.
• Responsible for escalating and facilitating product correction and removals (recalls, market withdrawals and stock retrievals) to ensure regulatory compliance and patient safety.
• Interface with distributors, sales force, international representatives and in-house departments for complaint, adverse event and incident reporting training and information.
• Responsible with communication to the FDA and international regulatory agencies for post-market surveillance activities (i.e., complaints, global adverse event and incident reporting). Providing training to employees, sales agents, sales representatives and customers regarding the regulatory requirements for complaint handling, adverse event reporting, corrections and removals, and corrective and preventive actions.
• Leading or participating in Regulatory and QMS audits (internal or external) to achieve successful audit outcomes.
• Ensuring that company procedures, processes and documentation meet the required guidelines for maintaining global compliance.
• Develop, monitor and maintain adequate systems to analyze and trend post-market data.
• Knowing and applying Advita’s Quality System and any appropriate federal and international standards.
  Assisting and supporting other employees, teams, and sales personnel as necessary.

Skills Knowledge and Expertise

Education:

• Bachelor’s Degree in a related field from an accredited institution required.

Experience:

• Extensive background in Medical Device Post-Market Surveillance or have the qualifications to make medical judgments preferred.
• Minimum 7 years’ experience in global medical device quality management system required.
• Minimum 7 years’ experience in global adverse event reporting requirements.
• Previous experience in complaint trending and complaint trend analysis
• Orthopedic device industry preferred.

Functional/Technical Knowledge, Skills and Abilities Required:

• Previous supervisory or management experience required.
• Technical writing skills required.
• Working knowledge of windows-based office productivity tools including word processor and spreadsheet.
• Preferred familiarity with a Quality Management Software solution (Trackwise, SmartSolve, etc.).