For our client, an international leader in pharmaceutical and medical products based in Sempach LU, we are currently looking for an experienced Quality/RA specialist in the field of Medical Devices for the following role:
Swiss Authorized Representative MDR
- Verify that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out.
- Keep available a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued in accordance with Article 56 of MedDO, at the dipsosal of competent authorities for the period of 10 years (15 years for implantable devices).
- Comply with the registration obligations laid down in Article 31 of MedDO and verify that the manufacturer has complied with the registration obligations laid down in Articles 27 and 29.
- In response to a request from Swismedic, provide all the information and documentation necessary to demonstrate the conformity of a device, in an official language within Switzerland.
- Cooperate with Swissmedic on any preventive or corrective action taken to elminate or, if that is not possible, mitigate the risks posed by devices.
- Academic degree in law, medicine, pharmacy, engineering or similar. At least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices is required.
- Alternatively at least four years of professional experience in regulatory affairs or in quality management systems relating to medical devices is required.
- Very good knowledge of the Medical Device Regulation. Pharmaceutical Swiss regulation is a plus.
- Experience with Swissmedic is an advantage.
- Fluent German, and excellent knowledge of English. French is a big plus, Italian is a plus
Please apply online. For further information about the position, please contact your Kelly recruiter, Mr. Thomas Meyer (+41 44 225 41 08).
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