Full-Time

Senior Post Market Surveillance Specialist

Updated on 6/6/2024

PROCEPT BioRobotics

PROCEPT BioRobotics

501-1,000 employees

Robotic system for minimally-invasive urologic surgery

Robotics & Automation

Senior

San Jose, CA, USA

Required Skills
Management
Requirements
  • 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.
Responsibilities
  • Perform maintenance and continuous improvements of the Post Market Surveillance (PMS) system for PROCEPT BioRobotics.
  • 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.
  • Collaborate with various teams to obtain accurate complaint information and complete adverse event reporting determinations per regulatory requirements.
  • Review, analyze, interpret, and summarize PMS data; draw conclusions, make recommendations, and prepare reports for management reviews.
  • Recognize complaint trends, potential product problems, and recalls, and initiate remedial action if appropriate.
  • Coordinate with management personnel in formulating company policies, procedures, and documentation.
  • Participate and support internal and external audits and inspections.
  • Maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System.

The AQUABEAM Robotic System by PROCEPT BioRobotics is an advanced, image-guided surgical robotic system designed for minimally-invasive urologic surgery, focusing on treating benign prostatic hyperplasia (BPH) through Aquablation therapy, which combines real-time imaging, personalized treatment planning, automated robotics, and heat-free waterjet ablation for targeted and rapid removal of prostate tissue. The technology utilizes real-time imaging, personalized treatment planning, automated robotics, and heat-free waterjet ablation for precise and rapid removal of prostate tissue.

Company Stage

IPO

Total Funding

$637.7M

Headquarters

San Jose, California

Founded

2009

Growth & Insights
Headcount

6 month growth

14%

1 year growth

39%

2 year growth

143%