Support the Quality Assurance & Regulatory Affair department by reviewing, evaluating, and performing Post Market activities on our medical devices, determining if they require vigilance reporting, trend reports, identifying supporting data and notifying regulatory agencies as necessary.
Support the team regarding complaint handling activities in accordance with company guidelines, regulatory requirements and standard ISO 13485, European Regulation (MDR), FDA 21 CFR part 820-803.
Act as an interface between Product Surveillance team and Regulatory, Quality, Clinical, R&D and Marketing team to gather appropriately PMS data.
Collect, trend and escalate data related to Post Market Surveillance.
Preparation and presentation of Post Market Surveillance Report to the Management
Generate, maintain and complete the Post Market documentation (Periodic safety update report, PMS report & Plan) subject to review by regulatory agencies.
Ensure that Post Market procedures, processes and documentation meet the required compliance guidelines and regulations
Support Product Surveillance system activities and trainings
Ensure preparation of analytical reports and statistics periodically or upon specific request.
Successful Bachelor's degree in life science or engineering (or related field)
Good knowledge of European Medical Device Regulation
1 to 2 years tin post-market surveillance and complaint management of medical devices (Complaint Evaluation / Safety assessment / Medical Device Reporting / Compliance).
Language: English (C1) & French (B1 minimum), German knowledge is an asset
Ability to work autonomously and accurate in every detail
Strong organizational, planning and analytical skills, results oriented.
Excellent communication and interpersonal skills, ability to work in international environment with cross-functional team
IT Tools: Excel (advanced), Word, Power Point, ERP (Microsoft Dynamics)