Senior Post Market Surveillance Specialist

Senior Post Market Surveillance Specialist

Requirements

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

Responsibilities

• Performs maintenance and continuous improvements of the Post Market Surveillance (PMS) system for PROCEPT BioRobotics.
• Independently assures timely complaint initiation, investigation/analysis, reportability assessments, and reporting to appropriate domestic and international governments, and complaint closures.
• Evaluate documentation for completeness and consistency and execute additional actions as necessary to close the complaint file.
• Perform Good Faith Efforts for product returns and obtain required information for complaint assessment and evaluation.
• Collaborate with medical affairs, customer service, global sales team, professional educators, and clinical specialists to obtain accurate complaint information.
• Complete adverse event reporting determinations per geography regulatory requirements for approved devices (US FDA, EU MDD/MDR, Health Canada, PMDA, NMPA, etc.) in a timely manner.
• Initiate, complete, and submit adverse event reports in an accurate and timely manner to the appropriate regulatory authorities within the required timeframe per applicable geography regulations.
• Review, analyze, interpret, and summarize PMS data; draw conclusions and make appropriate recommendations and decisions.
• Recognize complaint trends, potential product problems, and potential recalls, and initiate immediate remedial action, if appropriate.
• Prepare reports for management reviews, monthly complaint trend meetings, and other required reports, as requested.
• Work closely with the Design Quality Engineering team to update Risk Management files when new failure modes or new frequency of occurrence are identified.
• Initiate CAPA/SCAR to document improvements needed as a result of new failure modes or increases in complaint rates.
• Interface directly with internal and external customers and regulatory agencies as required.
• Participate in PMS activities such as generating PMS plans, PMS reports (PMS-R), and/or period update safety reports (PSUR) for PROCEPT BioRobotics devices.
• Prepare responses to customer requests for failure analysis results, as required.
• Coordinate with management personnel in formulating and establishing company policies, system-level procedures, and associated documentation.
• Participate and support internal and external audits and inspections, as needed.
• Maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance.
• Understand and adhere to the PROCEPT BioRobotics EHS policy.

Preferred Qualifications

• Working knowledge and experience with US FDA 21 CFR 803 Medical Device Reporting, US FDA 21 CFR 820, ISO 13485, MDSAP, EU MDR/MDD, vigilance reporting requirements, PMDA.
• Ability to work in a fast-paced environment with multiple tasks/projects.
• Excellent prioritizing, organizational, and interpersonal skills.
• A detail-oriented individual with a “can do” attitude and the ability to work in a team environment as well as individually (with minimal supervision).
• Able to work in a Hybrid role.