Senior Manager, Complaint & Post-Market Compliance

Kls-Martin-Group; Jacksonville (FL); On-site; USD 120,000 - 160,000; Full time

Job summary

Paycom, a Jacksonville-based leader in medical devices, seeks a Manager, Complaint Management and Post-Market Compliance to provide strategic and regulatory leadership for complaint handling, post-market surveillance, adverse event reporting, and field actions.

You will own the end-to-end complaint process, lead a team of specialists, ensure timely investigations, reportability determinations, and regulatory submissions while partnering with Legal and cross-functional groups to minimize risk and

Qualifications

• Bachelor's degree in life sciences, engineering, nursing, quality, regulatory affairs, or related discipline.
• Minimum 8 years of progressive medical device experience with complaint handling, post-market surveillance, or related regulatory functions.
• Minimum 3 years of direct people leadership in a complaint, post-market, vigilance, or regulatory organization.
• Expert working knowledge of FDA QMSR and ISO 13485, 21 CFR Parts 803 and 806, complaint handling, risk management, field actions and recalls, and applicable global vigilance requirements.
• Experience partnering with Legal, Product Liability, Risk Management, or outside counsel on adverse events, product claims, litigation, regulatory enforcement, or other sensitive post-market matters.

Responsibilities

• Provide strategic leadership for complaint management, post-market surveillance, MDR, global vigilance, and field action and recall activities.
• Own the complaint process from intake through closure, including timely evaluation, investigation coordination, reportability assessment, escalation, documentation, and approval.
• Lead complaint-related responses to FDA inspections, notified body and MDSAP audits, regulatory inquiries, audit findings, and remediation commitments.
• Establish complaint objectives, performance measures, organizational structure, service expectations, and resource plans aligned with priorities.
• Coordinate with Legal on patient inquiries, potential claims, litigation, regulatory enforcement matters, information requests, and confidentiality needs.
• Develop and supervise a capable complaint organization through coaching and succession planning.

Skills

Leadership

Regulatory knowledge

Data analysis

Communication

Education

Bachelor's degree in life sciences

Tools

QMS software

Job description

Paycom, a Jacksonville-based leader in medical devices, seeks a Manager, Complaint Management and Post-Market Compliance to provide strategic and regulatory leadership for complaint handling, post-market surveillance, adverse event reporting, and field actions.

You will own the end-to-end complaint process, lead a team of specialists, ensure timely investigations, reportability determinations, and regulatory submissions while partnering with Legal and cross-functional groups to minimize risk and