Post Market Surveillance Manager – Medical Devices

This is a fully remote position, open to applicants in United States.

📋 Description

• The Manager is tasked with creating an efficient and effective global program to audit quality systems and compliance areas, including FCPA, while ensuring a compliant Post Market Surveillance (PMS) program.

• Oversees and sustains the Owens & Minor Global QARAC Audit program.

• Integrates QARA and Compliance internal audit processes across Owens & Minor to fulfill customer and regulatory requirements; continuously monitored and enhanced; executes proficient auditors utilizing appropriate audit protocols.

• Oversees and sustains the Owens & Minor Global PMS program to comply with customer and regulatory standards.

• Responsible for identifying and enabling a team of qualified, independent internal QARAC auditors.

• Maintains a centralized record of all internal and third-party audits, findings, and the status of responses.

• Conducts proactive data analysis and fosters a culture of continuous improvement to identify opportunities and elevate the Owens & Minor global quality and compliance systems.

⛳️ Requirements

• Must possess experience with FDA reporting and compliance, particularly in relation to medical devices.

• Experience in managing a team is essential.

• Minimum of 4-5 years of relevant experience.

• A Bachelor's Degree is required.

• Experience with medical devices is mandatory.

🏝️ Benefits

• Comprehensive Healthcare Plan - Medical, dental, and vision plans commence on the first day of employment for full-time teammates.

• Educational Assistance - We provide educational assistance to all eligible teammates enrolled in an approved, accredited collegiate program.

• Employer-Paid Life Insurance and Disability - We offer employer-covered life insurance and disability coverage.

• Voluntary Supplemental Programs – Additional options are available to secure your financial future, including supplemental life, hospitalization, critical illness, and other insurance programs.

• Support for your Growing Family – We provide adoption assistance, fertility benefits (included in the medical plan), and parental leave for teammates planning for a family.

• Health Savings Account (HSA) and 401(k) - These voluntary financial programs are offered to help teammates prepare for their future, along with other optional benefits.

• Paid Leave - In addition to sick days and short-term leave, we provide holidays, vacation days, personal days, and various types of leave – including parental leave.

• Well-Being – Our offerings also include a Teammate Assistance Program (TAP), Calm Health, Cancer Resources Services, and discount programs – all at no cost to you.