Senior Post Market Surveillance Specialist

Company Overview

Embark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. At PROCEPT, we put the patient first in everything we do and 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.

Understanding PROCEPT's Culture

At PROCEPT, we believe every person matters. Every employee, every patient, every caregiver. Because we are here to create a revolution, and we believe in doing that by innovating everywhere with pathological optimism. We believe in being humble and highly engaged in the work we do, while also working together seamlessly for a common goal. At Procept, curiosity, ingenuity and conviction in the power technology will transform the lives of our patients and providers.

And this doesn’t happen by accident. It starts with our live induction program that serves as an incubator for cross-functional team building, an immersion in Procept’s history, jam-packed interactive sessions with executive leadership and a crash-course in the mission and purpose of what we do. It continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens.

We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU! At Procept, we push beyond just finding a work/life balance, we strive to find a work/life blend, a professional world that you are honored and impassioned to belong to, one that you can proudly share with your family, friends, and acquaintances.

An opportunity at PROCEPT BioRobotics won’t just be about finding a job. It will be an opportunity for you to join a community devoted to making a difference in this world!

Company Overview

Embark 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, and 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 that continuously learns from one another? Are you a leader who wants to make a difference and improve processes? Are you detail-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-oriented, solution-oriented, proactive, and self-managed will assist in the success of this position.

What Your Day-To-Day Will Involve:

• Independently assure 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.
• Perform maintenance and continuous improvements of the Post Market Surveillance (PMS) system for PROCEPT BioRobotics.
• Recognize complaint trends, potential product problems, and potential recalls, and initiate immediate remedial action, if appropriate.
• Support product recalls, corrections, removals, market withdrawals, and Field Safety Corrective Actions (FSCAs) in coordinator or Subject Matter Expert roles.
• Develop recall strategies, execute plans, customer communication drafts, and prepare and submit regulatory reports, recall notification packets, and closure requests to the FDA, EU Competent Authorities, and other global regulatory agencies.

• 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 periodic safety update reports (PSUR) for PROCEPT BioRobotics devices.
• Prepare responses to customer requests for failure analysis results, as required.
• Participate in 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.
• A minimum of 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 806 Corrections and Removals, 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.

Pay Range for this role: