For our partner, I am looking for a Regulatory Affairs Specialist that fits the spirit of a growing a high performing consultancy. This company is in an exciting phase of growth with a market-leading portfolio. In this role you’ll actively advise medical device manufacturers, importers and distributors and with implementing the Medical Device Regulation (MDR) within their organisation.
- Assist in the transfer of MDR In Vitro Diagnostic Regulation (IVDR).
- Uphold relevant documentation and ensure adherence to directives.
- Guide clinical evaluations for specific medical classes (1 and 2).
- Conduct risk analysis and providing consultancy services, advising the client throughout the process, including clinical evaluations.
- The consultant is assigned and responsible for specific projects, participating in project meetings and taking ownership.
- Assist in compiling and maintaining Technical Documentation in accordance with the MDR and relevant standards such as EN-ISO 14971 and EN-ISO 13485
- Establish and implement quality management systems in accordance with EN-ISO 13485 (Standard Operating Procedures (SOPs), work instructions and quality manuals)
- Assist with medical device registration in EUDAMED
- Assist in conducting internal quality audits and reviews to identify non-conformities and areas for improvement regarding MDR compliance
- Assist with communication and coordination with notified bodies during the MDR conformity assessment process.
- Relevant HBO/University in a scientific or technical discipline, such as Biomedical Engineering, Life Sciences, Pharmacy or possibly Law
- Minimum 2 years of experience in MDD and/or MDR and strong Regulatory Affairs (RA) background.
- Project management skills with a focus on client communication and consultancy.
- Dutch language proficiency preferred or open to learn (; English is a must)
- Affinity and interest in providing consultancy services
- Strong interest and ability to manage full project life cycles, projects can have a duration of several months to one-year.
ORGANISATION AND OFFER
Join a team of top specialists in the field of European (CE) & International product certification. Work with international clients in Europe, UK, the US and Australia, diving into different regulatory environments and have access to opportunities for personal and professional growth.
INTERESTED? Reach out to Aimee Brenner for more information by contacting +31 (0)20 20 44 502 or firstname.lastname@example.org