Beschreibung
For our client we are looking for Regulatory Affairs Expert (f/m/d).• Project Start: ASAP
• Project duration: 01.11.2021 - 31.12.2022
• Location: Ettlingen/Remote
• Language: English/German
The upcoming regulatory requirements are published but the interpretation of the text is still a moving target due to newly published guidances and specifications.
The scope of services includes the following tasks, which are independently performed by the external contractor:
- Independent writing of Technical documentation for our SV and VC products and final document review before submission
- Technical consultation on interpretation of MDR, MDCG or common specifications on request by the MDR project teams
- Independent review of the MDR compliance of all documents which are part of a Technical File, with a special focus on Regulatory documents like labelling, product classification or the main text of the technical documentation
- Providing input to the MDR teams for discussions with our Notified Bodies, mainly questions from the update of the Technical documentation for clarification with the Notified Body. The contractor should help the clarification process with the Notified Body (external certification bodies) by creating presentations to facilitate the discussions
- Contact point for MDR related customer requests on Regulatory information in EMEA and a response to the request will be provided by the contractor (to the J&J function which is in contact with the external information requestor)
- Contact point for Regulatory related audit questions for the MDR audits in Notified Body audits planned in EMEA)
- Independent review and test of the new Eudamed database
We need external expert knowledge on MDR regulations which we do not have within the regular Regulatory team.
The performance of the contractor in 2021 has the goal to create and submit the TechFiles for the Medical Device SV product family to the Notified Body.
The performance of the contractor has the overall goal to achieve the CE certification of all our products according to the new MDR regulation until May 2024.
If you are interested in this vacancy, we would be pleased to receive your updated CV, availability and your hourly rate with everything included.
Dominika Szukiewicz
Resource Consultant
Harvey Nash GmbH
Phone:
Email: