Expected Travel: Up to 10%

Requisition ID: 14465

Position Summary

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.

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.

Education / Experience 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.

Specialized Skills / Other 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.

What Success Looks Like
Success in this role means development of a sustainable, inspection-ready post-market program with timely complaint handling and reporting, effective signal detection, high-quality PMS/PSUR deliverables, and strong integration with risk management and clinical evidence.

#LI-AD1

#LI-remote

The pay range for this position at commencement of employment is expected to be between $115,500-$150,000, however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

At Ingenyx, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.