Advita Ortho

Orthopedic implants and AI-enabled surgical technologies

Manager – Post Market Surveillance

Regulatory & Quality (Life Sciences)Updated on Nov 13

Full-timeGainesville, FL, USANo salary listedIn-person

About the Job

Requirements

A Bachelor's degree in a related field from an accredited institution is required.
A minimum of 7 years of experience in global medical device quality management systems is required.
A minimum of 7 years of experience in global adverse event reporting requirements is required.
Previous experience in complaint trending and complaint trend analysis is required.
Previous supervisory or management experience is required.
Technical writing skills are required.
Working knowledge of Windows-based office productivity tools, including word processors and spreadsheets, is required.

Responsibilities

Lead and manage the QA Post-Market Team responsible for receiving, documenting, investigating, resolving, and trending customer complaints to ensure regulatory compliance and customer satisfaction.
Oversee the team responsible for determining and processing medical device adverse event and incident reporting requirements in compliance with federal and international regulations.
Escalate and facilitate product corrections and removals, including recalls, market withdrawals, and stock retrievals, to ensure regulatory compliance and patient safety.
Interface with distributors, the sales force, international representatives, and internal departments to provide complaint, adverse event, and incident reporting training and information.
Communicate with the FDA and international regulatory agencies regarding post-market surveillance activities, including complaints and global adverse event and incident reporting.
Provide training to employees, sales agents, sales representatives, and customers on regulatory requirements for complaint handling, adverse event reporting, corrections and removals, and corrective and preventive actions.
Lead or participate in internal and external regulatory and quality management system audits to achieve successful audit outcomes.
Ensure company procedures, processes, and documentation meet applicable guidelines for maintaining global compliance.
Develop, monitor, and maintain systems to analyze and trend post-market data.
Know and apply the company's Quality System and applicable federal and international standards.
Assist and support other employees, teams, and sales personnel as necessary.

Desired Qualifications

Extensive experience in medical device post-market surveillance or qualifications to make medical judgments is preferred.
Experience in the orthopedic device industry is preferred.
Familiarity with a Quality Management Software solution such as Trackwise or SmartSolve is preferred.

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.

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.

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.).

About the Company

Advita Ortho

Orthopedic implants and AI-enabled surgical technologies

Advita Ortho designs and sells orthopedic implants and integrated surgical technologies, including established lines like Equinoxe Shoulder, Vantage Ankle, Alteon Hip, and Truliant Knee. Its products pair implants with tools such as Newton balancing technology and GPS navigation to guide surgeries, while using data, AI, and machine learning to build a surgical ecosystem that supports in-OR decision-making. The company differentiates itself by combining hardware with data-driven software to improve efficiency and outcomes, backed by experienced leadership and significant financial support from its investors. Its goal is to deliver high-quality implants and connected surgical technology that enhance patient outcomes and streamline operating-room workflow globally.

Company size: 201-500
Company stage: Debt Financing
Total funding: $35M
Headquarters: Gainesville, FL
Founded: 2025

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