Post Market Surveillance Specialist

5 days ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. Direct message the job poster from elemed Senior Talent Partner | Medical Affairs | Clinical Affairs | Regulatory Affairs | Quality 🔎 Role: Post-Market Surveillance (PMS) Specialist 🔹 The Role & Company Join a well established, growing and dynamic company designing, developing and producing a Class III active implantable medical device that changes the lives of patients. This is a great opportunity to join a close knit team with one vision, surrounded by other senior experts in their field. You will work with some of the top Quality and RA teams with high risk device Class III experience, allowing you to develop your skills and further develop your career. This is a position reporting to the Vice President of QARA so you can be sure that you will have an impact on patients’ lives and the company’s quality systems through your PMS activities. As a PMS Specialist, you’ll take lead on a range of responsibilities covering complaints handling and investigation, as well as vigilance reporting in global markets such as the USA, Canada and Europe. You will be given freedom and responsibility to improve the Quality Systems by creating new SOPs, new CAPA processes for the company, through your expertise in PMS activities. 🔸 As the PMS Specialist your responsibilities will include but not be limited to: Lead and manage field feedback activities from global markets (US, Canada, Europe) Lead and manage complaint management and investigation processes from start to finish Play a critical role in vigilance reporting (particularly with the FDA) and decision-making process Manage PMS data, performing impact assessments from global regulatory changes, create new KPIs and reports for senior management Generate new SOPs, new CAPA processes in order to be compliant with PMS and Vigilance Reporting standards Supporting external audits from a PMS perspective Minimum 3 years in the medical device industry in complaints handling and vigilance reporting reporting (under MDR, ISO 13485, and FDA and 21 CFR Part 820) Experience with FDA reporting for medical devices (under 21 CFR Part 803) Excellent communication skills in English. German would be a bonus. ✉️ Interested to explore this further? Please send your CV to Frankie@elemed.eu to arrange a confidential career discussion. 📲 Would you like to find out more about our open opportunities? Visit https://www.elemed.eu/vacancies/ Please note: Only candidates meeting the requirements set out in the role profile above, will be considered in the application process. Due to the high volume of applications we receive, our team might not be able to contact each applicant individually regarding the status of their application. If you do not hear from us after 10 days, please consider your application unsuccessful. ___________________________________________________________________ 🩺 Elemed is Europe’s leading MedTech technical recruiter. We serve within the Medical device, diagnostic and combination device arena, working with Managers up to VP of Quality and Regulatory. Our team helps medical device experts of today become leaders of tomorrow. At Elemed, we recruit exceptional people that solve regulatory and compliance problems, so patients can have access to safe, innovative and life-changing Medical Devices. ⚖️ We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. #J-18808-Ljbffr