Global Post-Market Surveillance & Vigilance Lead

Teleflex; United States; À distance; USD 116 000 - 150 000; Plein temps

Avantages offerts par ce poste

Medical, prescription drug, dental and

Vision insurance

401(k) savings plan

PTO and disability

Résumé du poste

Ingenyx is seeking an experienced Post-Market Surveillance, Vigilance & Complaints Lead to manage global post-market activities for medical devices. You will handle complaints, vigilance, PSURs, and signal detection, serving as the SME for post-market regulatory requirements and collaborating with Regulatory Affairs, Quality, Risk Management, and engineering teams.

The role requires strong regulatory judgment, extensive post-market experience, and the ability to lead cross-functional efforts

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, Quality, or a related technical or scientific discipline.
• 8+ years in medical device post-market roles (complaint handling, PMS, vigilance, regulatory affairs, quality).
• Demonstrated experience with medical device complaint investigations and regulatory reportability.
• Strong knowledge of EU MDR PMS and vigilance requirements including PSURs and PMS reports.
• Working knowledge of FDA Medical Device Reporting and global post-market regulations.
• Experience supporting regulatory inspections and audits.

Responsabilités

• Lead complaint handling process for Legal Manufacturer products, ensuring documentation, investigations, assessments and closure.
• Oversee investigations at manufacturing sites, suppliers, contract manufacturers and experts with accountability.
• Lead global vigilance and reportability assessments and ensure timely AE reports.
• Lead PMS program, including PMS plans/reports, trending, signal detection and evaluation of safety issues.
• Own PSUR process from planning to cross-functional review and timely completion.
• Integrate post-market information into risk management, CAPA, and quality system processes.
• Provide data for CER, PMCF, SSCP, PSUR and other clinical evidence activities.
• Partner with Regulatory Affairs on clinical evidence strategy and governance.
• Support field actions, recalls, FSCAs, and other safety actions as applicable.
• Serve as SME during regulatory inspections and Notified Body/MDSAP audits.
• Monitor evolving post-market/vigilance requirements and implement regulatory changes.

Connaissances

Analytical

Technical writing

Communication

Cross-functional leadership

Regulatory affairs knowledge

Formation

Bachelor's degree in Life Sciences

RAC/ASQ certification

Description du poste

Ingenyx is seeking an experienced Post-Market Surveillance, Vigilance & Complaints Lead to manage global post-market activities for medical devices. You will handle complaints, vigilance, PSURs, and signal detection, serving as the SME for post-market regulatory requirements and collaborating with Regulatory Affairs, Quality, Risk Management, and engineering teams.

The role requires strong regulatory judgment, extensive post-market experience, and the ability to lead cross-functional efforts