[Hiring] Post Market Surveillance, Vigilance and Complaints Lead @Teleflex

Role Description

We are seeking an experienced Post-Market Surveillance, Vigilance & Complaints Lead to manage global post-market activities for medical devices for which the company is a Legal Manufacturer. This role is responsible for:

• Complaint handling, vigilance and adverse event reporting
• Post-market surveillance, signal detection and trending
• Periodic Safety Update Reports (PSURs)

The Lead will serve as the primary subject matter expert for post-market regulatory requirements and partner closely with Regulatory Affairs, Quality, Risk Management, Engineering, Operations, and external clinical experts. This senior individual contributor/functional leadership role requires strong technical expertise, regulatory judgment, and the ability to lead cross-functional activities across a global organization.

Principal Responsibilities

• Lead complaint handling process for Legal Manufacturer products, ensuring complaints are appropriately documented, investigated, assessed, and closed.
• Oversee complaint investigations carried out by manufacturing sites, suppliers, contract manufacturers, and technical experts while maintaining Legal Manufacturer accountability.
• Lead global vigilance and reportability assessments and ensure adverse event reports are submitted within applicable timelines.
• Lead the global Post-Market Surveillance program, including PMS Plans/Reports, complaint trending, signal detection, and evaluation of emerging safety or performance issues.
• Own the PSUR process from planning and compilation through cross-functional review and timely completion.
• Ensure post-market information is appropriately incorporated into product risk management, CAPA, Management Review, and other Quality System processes.
• Provide complaint, vigilance, and PMS data for CER, PMCF, SSCP, PSUR, and other clinical evidence activities.
• Partner with Regulatory Affairs, which retains ownership of clinical evidence strategy, CER/CEP governance, PMCF strategy, SSCP governance, clinical vendor management, and final manufacturer approval.
• Support evaluation and execution of field actions, recalls, corrections/removals, FSCAs, and other product safety actions, as applicable.
• Serve as the primary complaint/PMS/vigilance subject matter expert during regulatory inspections, Notified Body audits, and MDSAP audits.
• Monitor evolving global post-market and vigilance requirements and support implementation of applicable regulatory changes.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, Quality, or a related technical or scientific discipline.
• 8+ years of medical device industry experience in complaint handling, PMS, vigilance, Regulatory Affairs, Quality, or related post-market functions, including 5+ years of direct post-market experience.
• Demonstrated experience with medical device complaint investigations and regulatory reportability assessments.
• Strong knowledge of EU MDR PMS and vigilance requirements, including PSURs, PMS Reports, trend reporting, and vigilance.
• Working knowledge of FDA Medical Device Reporting requirements and global post-market regulations.
• Experience with complaint trending, signal detection, and integration of post-market data into ISO 14971 risk management.
• Experience supporting regulatory inspections, Notified Body audits, and/or MDSAP audits.
• Strong analytical, technical writing, communication, and cross-functional leadership skills.

Requirements

• 10+ years of medical device industry experience.
• Experience leading global complaint handling, PMS, or vigilance programs for a Legal Manufacturer.
• Experience with post-market requirements in the U.S., EU, Canada, UK, Australia, Japan, Brazil, and Switzerland.
• Experience preparing and leading PSURs; experience supporting CER, PMCF, and SSCP activities.
• Experience working with external Medical Directors, clinical consultants, biostatisticians, or other specialized clinical resources.
• RAC, ASQ, or equivalent professional certification.

Benefits

• Medical, prescription drug, dental and vision insurance
• Flexible spending accounts
• Participation in 401(k) savings plan
• Various paid time off benefits, such as PTO, short- and long-term disability and parental leave

Company Description

Ingenyx is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.