Currently we support our customer in the medical devices industry in the location of Baden-Württemberg with the search for an experienced
Freelancer technical Documentation (m/f/d) MDR
Start is as soon as possible, the duration of the project is planned until end of December 2021.
Fulltime capacity with 100% remote work. The goal for this project is to create and submit the TechFiles for the Medical Device SV product family to the Notified Body & achieve the CE certification of all our products according to the new MDR regulation until May 2024.
- Support in writing of Technical documentation for SV & VC products and final document review by the company before submission in the aspects of regulatory affairs
- Technical consultation on interpretation of latest medical device regulations: MDR, MDCG or common specifications on request by the MDR project teams
- Support in reviewing 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
- Support the clarification process with the Notified Body (external certification bodies) by creating presentations to facilitate the discussions
- Act as 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 internal company's function which is in contact with the external information requestor)
- Act as contact point for Regulatory related audit questions for the MDR audits in 2021 (2 Notified Body audits planned in EMEA)
- Review and test of the new Eudamed database
- Background in medical engineering & medical devices
- At least 8 years` of industrial experience, medical industry preferred
- Strong background in the required fields of reviewing & ad missioning Technical documentation for MDR
- Expereience in working with the Eudamed database
- Good analytical skills & Good technical writing skills
- Precise method of working
Are you interested to learn more about this freelance project ? Please don't hesitate and send your profile with your hourly all-in rate for this role at firstname.lastname@example.org.
Kelly Services ist Ihr Spezialist für die Vermittlung von Fach- und Führungskräften. Wir bringen Sie mit genau dem Unternehmen zusammen, das zu Ihnen passt. Eine Vermittlung über uns ist persönlich, vertraulich und unkompliziert.
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