Manager, Post Market Surveillance

Advita Ortho • Gainesville, FL

5h • Onsite

About The Position

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.

Requirements

• Bachelor’s Degree in a related field from an accredited institution required.
• Minimum 7 years’ experience in global medical device quality management system required.
• Minimum 7 years’ experience in global adverse event reporting requirements.
• Previous supervisory or management experience required.
• Technical writing skills required.
• Working knowledge of windows-based office productivity tools including word processor and spreadsheet.

Nice To Haves

• Extensive background in Medical Device Post-Market Surveillance or have the qualifications to make medical judgments preferred.
• Previous experience in complaint trending and complaint trend analysis
• Orthopedic device industry preferred.
• Preferred familiarity with a Quality Management Software solution (Trackwise, SmartSolve, etc.).

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager