EDUCATION, EXPERIENCE, SKILLS
- Master’s degree in scientific disciplines, preferably clinical biotechnologies, biomedical sciences, biology, bioengineering
- 4/5 years of experience in Clinical and Regulatory Affairs with class III/IIb medical devices
- In-depth knowledge of the following legislations (included subsequent amendments), guidelines and standards: Directive 93/42/EEC, Regulation (EU) 2017/745, MDCG guidance, ISO 13485, ISO14155, ISO14971
- Fluent in English
- Able to work independently
- Experience in leading and organising project teams
MAIN ACTIVITIES
- Management of post-market surveillance and post-market clinical follow-up processes: development of plans, drafting reports, and coordination in the development of various planned activities (literature review and evaluation, collection and analysis of clinical data, literature review of similar medical devices, review and update of applicable standards and guidelines)
- Management and coordination of clinical studies in compliance with GCP, ISO14155, Medical Device Regulation 2017/745, protocol, SOPs, and applicable regulatory requirements: essential documents preparation, submission to and communication with Ethics Committees and Regulatory Authorities, monitoring, coordination of activities for the supply the IMD and all other necessary materials
- Management of vigilance reporting process and trend analysis
- Handling of feedbacks from the market: conducting investigations and coordinating with clinical experts
- Support in managing the QMS in accordance with ISO 13485:2016, particularly in drafting and updating procedures related to the clinical and regulatory processes
- Management of the Clinical Evaluation process
- Managing, updating, and monitoring the regulatory process to place the product on the market in various non-EU countries
- Review of technical-commercial documentation to support the customers (marketing material, website content)
- Active participation during the conduct of audits by Notified Bodies and external organizations
- Support the management of technical files filing and MDR transition
- Contribute to define and develop regulatory strategies for product development
