Senior Post Market Surveillance Specialist

Company OverviewEmbark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. We are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH, otherwise known as prostate gland enlargement) through innovation in surgical robotics. As our company succeeds and grows, we improve the quality of life of patients, provide more effective treatment options for surgeons, uphold the trust of our shareholders. That starts with a commitment to our People with a focus on creating an evolving landscape for your career, brimming with transformative opportunities that provide continuous career growth opportunities.
The Opportunity That Awaits You:   Do you want to be part of an innovative, cutting-edge technology, robotics company that is changing how BPH is treated? Are you looking to be part of an enthusiastic, driven, passionate and challenging team, who continuously learn from one another? Are you a leader who wants to make a difference and improve processes? Are you detailed-oriented? At PROCEPT BioRobotics you will have an opportunity to contribute and greatly support our continuous improvement philosophy by being part of our Post Market Surveillance Team. You will work with cross-functional teams to maintain and improve the complaint handling and Post Market Surveillance functions within the requirements of FDA's Quality System Regulation (QSR), ISO 13485 (ISO), MDSAP, EU MDR, and NMPA. Being detail and solution-oriented, proactive, and self-managed will assist in the success of this position.

What Your Day-To-Day Will Involve:

• 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.

The Qualifications We Need You to Possess

• 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.

The Qualifications We Would Like You to Possess

• 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 envi