Senior Post Market Surveillance Specialist

PROCEPT BioRobotics • San Jose, CA

1d • $112,230 - $132,030 • Hybrid

About The Position

PROCEPT BioRobotics is seeking a Senior Post Market Surveillance Specialist to support and improve its complaint handling and post-market surveillance functions for medical devices. The role works with cross-functional teams to maintain compliance with FDA Quality System Regulation requirements and applicable standards and regulations, including ISO 13485, MDSAP, EU MDR, and NMPA. The position calls for a detail-oriented, solution-oriented, proactive, and self-managed individual who supports continuous improvement.

Requirements

• Bachelor’s degree in engineering or life science, or equivalent knowledge gained through a combination of education and experience.
• At least 5 years of complaint handling experience and/or post-market surveillance experience in the medical device or a regulated industry.

Nice To Haves

• Working knowledge and experience with US FDA 21 CFR 803 Medical Device Reporting, US FDA 21 CFR 806 Corrections and Removals, US FDA 21 CFR 820, ISO 13485, MDSAP, EU MDR/MDD, vigilance reporting requirements, and PMDA.
• Ability to work in a fast-paced environment while managing multiple tasks and projects.
• Excellent prioritizing, organizational, and interpersonal skills.
• Detail-oriented, can-do approach and ability to work both in a team and independently with minimal supervision.
• Ability to work in a hybrid role.

Responsibilities

• Assure timely complaint initiation, investigation and analysis, reportability assessments, regulatory reporting, and complaint closure.
• Review complaint documentation for completeness and consistency and take additional actions as needed to close complaint files.
• Perform Good Faith Efforts to obtain product returns and required information for complaint assessment and evaluation.
• Collaborate with medical affairs, customer service, global sales, professional educators, and clinical specialists to obtain accurate complaint information.
• Determine adverse-event reporting obligations for approved devices according to applicable geographic requirements, and prepare and submit reports to regulatory authorities within required timeframes.
• Review, analyze, interpret, and summarize post-market surveillance data; draw conclusions and make recommendations and decisions.
• Maintain and continuously improve the Post Market Surveillance system.
• Identify complaint trends, potential product problems, and potential recalls, and initiate remedial action when appropriate.
• Support product recalls, corrections, removals, market withdrawals, and Field Safety Corrective Actions as a coordinator or subject matter expert.
• Develop recall strategies; execute plans; draft customer communications; and prepare regulatory reports, notification packets, and closure requests for the FDA, EU Competent Authorities, and other global agencies.
• Prepare management review reports, monthly complaint trend meeting materials, and other required reports.
• Work with Design Quality Engineering to update Risk Management files when new failure modes or changes in frequency of occurrence are identified.
• Initiate CAPA/SCAR documentation for improvements needed due to new failure modes or increased complaint rates.
• Interface with internal and external customers and regulatory agencies as required.
• Participate in post-market surveillance activities, including generating PMS plans, PMS reports (PMS-R), and/or periodic safety update reports (PSUR).
• Prepare responses to customer requests for failure analysis results as required.
• Participate in and support internal and external audits and inspections.
• Maintain trained status and comply with relevant aspects of the Quality Management System to support product and regulatory compliance.
• Understand and adhere to the PROCEPT BioRobotics EHS policy.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior