Global PMS & Regulatory Manager, Medical Devices (Remote)

Halyard Health; United States; On-site; USD 100,000 - 118,000; Full time

Job summary

Owens & Minor is seeking a Remote Post Market Surveillance Regulatory Manager to lead global QARAC Audit and PMS programs for medical devices. The role oversees audit harmonization, compliance monitoring, and data analysis with a focus on eMDR and Vigilance reporting.

A Bachelor's degree and 4–5 years of leadership in regulatory affairs are required. The position emphasizes continuous improvement, centralized documentation, and monthly dashboard reporting, with a salary range of

Qualifications

• Must have experience with FDA reporting and compliance specifically with medical devices.
• Experience managing a team (minimum 4-5 years) in a regulated environment.
• Bachelor's degree; medical devices experience preferred.
• Strong data analysis and audit coordination skills.

Responsibilities

• Lead and maintain the global QARAC Audit program across Owens & Minor.
• Harmonize internal audit processes to meet regulatory requirements and improve efficiency.
• Oversee the Global PMS program, including eMDR and Vigilance reporting.
• Maintain centralized logs of audits, findings and responses; ensure timely closure.
• Provide monthly metric reports and share best practices across the organization.

Skills

FDA reporting experience

Regulatory compliance

Team management

Data analysis

Audit execution

Education

Bachelor's Degree

Job description

Owens & Minor is seeking a Remote Post Market Surveillance Regulatory Manager to lead global QARAC Audit and PMS programs for medical devices. The role oversees audit harmonization, compliance monitoring, and data analysis with a focus on eMDR and Vigilance reporting.

A Bachelor's degree and 4–5 years of leadership in regulatory affairs are required. The position emphasizes continuous improvement, centralized documentation, and monthly dashboard reporting, with a salary range of