Our client is one of the world's largest medical technology companies who are addressing some of the most challenging global health issues. They provide innovative solutions that advance medical research, enhance diagnoses and improve medication management.
This a great opportunity to build upon your professional knowledge of global market clearance procedures as well as active and disposable standards compliance.
The individual has to gain department and platform influence by co-operating in all RA accomplishments and sharing regulatory knowledge of demonstrating compliance with changing global regulations.
- Prepare and maintain regulatory files such as STED and MDD/MDR Technical Files;
- Lead and execute OUS international product registrations attending to individual country specific requirements; monitor and report progress
- Participation in cross-functional product development teams as the regulatory representative; development of regulatory strategies
- Assesses changes in regulations and helps to determine their impact;
- Participate to the review of process/product changes, labeling, claims, product complaints, A&Ps (Advertising & Promotional materials), etc., to determine the need for any regulatory activities and to ensure compliance to International requirements;
- Attends to audits performed by internal and external authorities to represent RA positions and processes;
- Prepare regulatory dossiers for submission to Health Authorities and maintains them along the whole product life-cycle
- Proven regulatory affairs experience within the medical technology industry
- Sound knowledge of the regulatory framework pertaining to Medical Devices such as the MDD CE Marking
- Demonstrated compliance experience with all MDD classes medical devices, possibly including (P)EMS - (Programmable) Electrical Medical Systems;
- Experience in International Standards in particular: ISO 13485, ISO 14971 and IEC 60601 series;
- Good working knowledge of Design Control, Software Life Cycle, Risk Mngt, V&V (e.g. BioCompatibility) processes;
- Solid knowledge and material experience in International registrations/approval process for medical devices
- Strong knowledge in international standards and regulations including ISO13485, EN60601, EN62304, ISO 10993, ISO14971 and Medical Devices Directives.