Post Market Surveillance Director

3 weeks ago


Tampa, Florida, United States FloodGate Medical Inc Full time

FloodGate Medical Inc is seeking a highly skilled and experienced Post Market Surveillance Director to join their team. As a key member of the organization, you will be responsible for overseeing the post-market surveillance team and activities for medical devices and medical devices distributed by the company across all jurisdictions. This role ensures compliance with regulatory requirements, monitors product performance, and manages adverse event reporting. The ideal candidate will have extensive experience in post-market surveillance in the medical device environment, a deep understanding of regulatory requirements, and strong analytical skills. They will also have a minimum of 7-10 years of experience in post-market surveillance or a related field within the medical device industry, preferably Class III implantable devices. In-depth knowledge of regulatory requirements (e.g., FDA, EU MDR) and industry standards (e.g., ISO 13485, ISO 14971) is essential. Additionally, experience with data analysis tools and software, as well as strong analytical and problem-solving skills, are required. The successful candidate will have excellent communication and interpersonal skills and be able to work effectively in a clinical environment. This role will involve developing and implementing post-market surveillance plans, managing all post-market reporting requests, and streamlining the PMS process and associated procedures across jurisdictions. The candidate will also be responsible for monitoring the analysis of data from various sources, overseeing investigations into product complaints and adverse events, and preparing and submitting regulatory reports. They will work collaboratively with cross-functional teams, including R&D, Quality, and Regulatory Affairs, to address product issues and implement corrective actions. The estimated salary for this role is around $120,000 - $150,000 per year, depending on location and experience. Benefits include medical, dental, and vision coverage, 401k with company match, and vacation time. If you are a motivated and experienced professional looking for a new challenge, please consider this exciting opportunity with FloodGate Medical Inc.



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