INGENYX- Post Market Surveillance, Vigilance and Complaints Lead
About The Position
Ingenyx, a new independent company following its divestiture from Teleflex, is a leading global provider of product development and production services for medical device manufacturers. 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, and 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.
Requirements
- 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.
Nice To Haves
- 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.
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.
Benefits
- medical
- prescription drug
- dental insurance
- vision insurance
- flexible spending accounts
- 401(k) savings plan
- PTO
- short-term disability
- long-term disability
- parental leave
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What This Job Offers
Job Type
Full-time
Career Level
Senior
