Senior Post Market Surveillance Specialist - PROCEPT BioRobotics

CORE RESPONSIBILITIES

• Performs maintenance as well as 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 as well as international governments, and complaint closures.
• Evaluates documentation for completeness and consistency and execute additional actions as necessary to close the complaint file.
• Perform Good Faith Efforts for product return and to 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, 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

QUALIFICATIONS (Education, Experience, Certifications)

• 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).

PHYSICAL DEMANDS & WORK ENVIRONMENT

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• To perform this duty the employee must have the ability to sit or stand at and operate a computer terminal and walk or travel safely within the facility. The employee may occasionally lift and/or move up to 25 pounds.
• While performing the duties of this job, the employee regularly works in an office environment. The employee will occasionally be exposed to engineering labs. The environment is subject to moderate noise from machinery (IE machine shop equipment, the PROCEPT Aquablation unit, computer equipment, printers, etc.), for which proper hearing protection may be assigned and worn. The employee may be exposed to hazards including electrical sparking, water, and chemicals, for which proper protective equipment will be assigned and worn.
• The above statements are intended to describe the general nature and level of work being performed.
• They are not intended to be construed as an exhaustive list of all responsibilities.

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