Post Market Clinical Quality

Real Staffing Group; United States; A distancia; USD 120.000 - 180.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Fully remote flexibility

Descripción de la vacante

Specialist Staffing Group is seeking a Senior Clinical Quality individual to lead post-market surveillance for implantable cardiac devices. You will assess adverse events, regulatory reportability, and drive patient safety initiatives.

The role is fully remote, offering strong compensation and cross-functional exposure across Quality, Regulatory, Clinical, R&D, and Manufacturing teams. A BS in biomedical engineering or nursing and an active RN license are required.

Formación

• 5+ years in Post-Market Surveillance, Complaint Handling, Clinical Quality, or Medical Device Quality.
• BS degree in Biomedical Engineering, Nursing, or related medical field; RN license preferred.
• Deep knowledge of FDA quality and post-market regulations in medical devices.

Responsabilidades

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

Conocimientos

Post-Market Surveillance

Complaint Handling

Clinical Quality

Regulatory Reporting

Educación

BS in Biomedical Engineering

RN Licensure

Descripción del empleo

Are you passionate about improving patient outcomes through cutting-edge cardiac technologies?

I'm partnering with a well-funded medical device company that recently received PMA approval for a breakthrough Class III CRT technology and is expanding its Clinical Quality and Post-Market Surveillance team. This is an opportunity to play a critical role in monitoring device performance, driving patient safety initiatives, and serving as a key clinical quality leader within a highly collaborative organization.

What You'll Be Doing

• Lead post-market surveillance and complaint handling activities 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 teams
• Support root cause investigations and identify emerging safety or performance trends
• Own and support FDA MDR submissions and global vigilance reporting
• Help drive continuous improvement of post-market quality processes and patient safety initiatives

What We're Looking For

• 5+ years of Post-Market Surveillance, Complaint Handling, Clinical Quality, or Medical Device Quality experience
• BS degree in Biomedical Engineering, Nursing, or related medical field
• Active RN or clinical license
• Strong background with Cardiac Rhythm Management (CRM), CRT, electrophysiology, pacemakers, ICDs, leadless pacing systems, or other implantable cardiac technologies
• Experience evaluating clinical complaints, adverse events, and regulatory reporting requirements
• Deep knowledge of FDA quality and post-market regulations within the medical device industry

Why Consider This Opportunity

• Fully remote flexibility
• Strong compensation package
• Newly approved, commercial-stage Class III technology
• High visibility role with cross-functional leadership exposure
• Opportunity to directly impact patient safety and the future of cardiac resynchronization therapy

In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.