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. 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.

• 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.

• 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.

• 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.

For US-Based Candidates Only

Work Authorization Status: Citizen / Permanent Resident

For this role, the anticipated base pay range is $117,000-135,000 per year.

Plus, eligibility for an annual bonus and equity/RSUs

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!

BENEFITS OF WORKING AT PROCEPT! 

PROCEPT’s health and wellness benefits for employees are second to none in the industry. As an organization, one of our top priorities is to maintain the health and wellbeing of our employees and their families. We offer a comprehensive benefits package that includes full medical coverage, wellness programs, on-site gym, a 401(k) plan with employer match, short-term and long-term disability coverage, basic life insurance, wellbeing benefits, flexible or paid time off, paid parental leave, paid holidays, and many more!

EQUAL EMPLOYMENT OPPORTUNITY STATEMENT

PROCEPT BioRobotics is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind on the basis of race, color, national origin, religion, gender, gender identity, sexual orientation, disability, genetic information, pregnancy, age, or any other protected status set forth in federal, state, or local laws. This policy applies to all employment practices within our organization.

PAY RANGE TRANSPARENCY

Procept is committed to fair and equitable compensation practices. The pay range(s) for this role is listed below and represents base salary range for non-commissionable roles or on-target earnings for commissionable roles. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, relevant certifications and training, and specific work location. Based on the factors above, Procept utilizes the full width of the range. The total compensation package for this position may also include eligibility for annual performance bonus, equity, and the benefits listed above.

WORK ENVIRONMENT

We’ll provide you training for, and ask you to maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance. We would also ask you to understand and adhere to the PROCEPT BioRobotics Quality & EHS policies.