Senior Regulatory Affairs Specialist

Berlin, Germany

Senior Regulatory Affairs Specialist – Medical Device

Xplore Life Science is recruiting for Senior Regulatory Affairs Specialist to join a leading medical device company, that has a global presence. The role is suitable would like to provide and maintain regulatory support, supply regulatory input and data and ensure compliance with standards.

Responsibilities

  • Ensure compliance to global regulatory requirements and company policies
  • Interface and co-ordinate with regulatory agencies; deliver regulatory input and appropriate follow up support to inspections and audits (e.g. FDA, Notified Bodies etc)
  • Provide input to the risk management process, procedure improvements, management review and support new product development activities
  • Other tasks may be required to support the activities of the Regulatory Affairs department and the Company

Requirements

  • Must be fluent in German and English to provide responses to technical queries in either language to authorities/agencies
  • 2 – 3 years’ experience in a Regulatory Affairs role in a medical device company

Why should you apply?

  • You would be the PRRC for Europe, based in the German office, in Berlin
  • Offers a hybrid working environment
  • The company is established within the medical device industry, with extensive funds and investments
  • The salary will range between €80,000 - €90,000

 

Apply now