Part-Time Regulatory Affairs Specialist

  • Location

    Würzburg, Germany

  • Sector:

    Regulatory Affairs

  • Salary:

    55,000EUR pro rata

  • Contact:

    Rebecca Stevens

  • Job ref:

    20406

  • Published:

    4 months ago

  • Expiry date:

    2021-05-26

Our client is a global manufacturer of respiratory devices and currently have an important focus on 510k submissions in collaboration with American colleagues, plus the EU MDR.

On a part-time basis, they are looking for a Regulatory Affairs Specialist to be responsible for technical documentation for class IIa MDR medical devices in cooperation with the R&D team. You will also support our local teams worldwide with country-specific product registration.

Your responsibilities:

• Preparation and maintenance of the EU MDR Technical Documentation for product registration

• Support of the development department in documentation and regulatory issues

• Regulatory support for the development department (design projects, design changes)

• Monitoring of (inter) national regulations and changes in legislation

• Support in post-market surveillance according to MDD / EU MDR and other international regulations

 

Your experience:

• Bachelor in Engineering or science or any other relevant discipline

• 2+ years of practical experience in medical technology and regulatory affairs

• Experience in the approval of medical devices with in-depth knowledge in the area of ??MDD / EU MDR

• Very good knowledge of German and English

 

To discuss this role and further opportunities in Regulatory Affairs, please contact Rebecca Stevens at Rebecca.Stevens@adaptivelifescience.com