Bachelor's degree in engineering, life science, or equivalent experience.
Minimum of 5 years in complaint handling or post-market surveillance in medical devices or regulated industries.
Familiarity with US FDA regulations and ISO standards related to medical devices.
Strong organizational and prioritization skills in a fast-paced environment.
Detail-oriented with a proactive, solution-focused mindset.
Responsibilities
Ensure timely initiation and closure of complaints and investigations.
Evaluate documentation for completeness and execute necessary actions for complaint resolution.
Collaborate with cross-functional teams to gather accurate complaint information.
Complete adverse event reporting per regulatory requirements in a timely manner.
Analyze PMS data to identify trends and recommend actions for product issues.
Support product recalls and develop communication strategies for regulatory submissions.
Prepare management reports and participate in audits and inspections.
Benefits
Opportunity to work in an innovative robotics company.
Collaborative and passionate team environment.
Focus on continuous improvement and professional development.
Hybrid work model available.
Full Job Description
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: $112,230 to $132,030
About PROCEPT BioRobotics
PROCEPT BioRobotics is a medical device company that develops and commercializes the AquaBeam System, a minimally invasive surgical platform for the treatment of prostate disease. The company was founded in 2010 and is headquartered in Redwood City, California. The AquaBeam System uses high-pressure water to remove prostate tissue without damaging surrounding tissue. The company has raised over $120 million in funding to date.
