Senior Post-Market Quality Lead - Cardiac Implants (Remote)

Real; United States; Remote; USD 110,000 - 170,000; Full time

Benefits offered by this job

Fully remote

Competitive compensation

Cross-functional exposure

Job summary

Specialist Staffing Group seeks an experienced Post-Market Surveillance leader for implantable cardiac devices. You will oversee post-market surveillance, complaint handling, and regulatory reporting, collaborating across Quality, Regulatory, Clinical, R&D and Manufacturing to safeguard patient safety.

The role emphasizes leadership in cross-functional teams, root-cause investigations, and MDR submissions, with a strong remote-capable, high-impact environment.

Qualifications

• 5+ years in Post-Market Surveillance, Complaint Handling, Clinical Quality, or Medical Device Quality
• Active RN or clinical license
• Deep knowledge of FDA quality and post-market regulations in medical devices

Responsibilities

• Lead post-market surveillance and complaint handling for implantable cardiac devices
• Assess device performance concerns, adverse events, and regulatory reportability
• Serve as the clinical and technical quality SME across Quality, Regulatory, Clinical, R&D, and Manufacturing
• Support root cause investigations and identify safety/performance trends
• Own FDA MDR submissions and global vigilance reporting
• Help drive continuous improvement of post-market quality processes and patient safety

Skills

Post-market surveillance

Complaint handling

Clinical quality

FDA quality regulations

Regulatory reporting

Education

Biomedical Engineering / Nursing or related field

Job description

Specialist Staffing Group seeks an experienced Post-Market Surveillance leader for implantable cardiac devices. You will oversee post-market surveillance, complaint handling, and regulatory reporting, collaborating across Quality, Regulatory, Clinical, R&D and Manufacturing to safeguard patient safety.

The role emphasizes leadership in cross-functional teams, root-cause investigations, and MDR submissions, with a strong remote-capable, high-impact environment.