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Regulatory Affairs Manager

  • Location

    Germany

  • Sector:

    Regulatory Affairs

  • Salary:

    80,000EUR

  • Contact:

    Rebecca Stevens

  • Job ref:

    23067

Regulatory Affairs Expert

 

Do you enjoy working with many different clients, ensuring their regulatory compliance as well as supporting them in achieving their CE-marking across the European market?

Read on!

Our client – a well-established Consultancy is currently looking for a Regulatory Affairs Expert to strengthen their international team.

 

Responsibilities:

  • Compilation of Technical Documentations.

  • Ensure fulfilment of EU requirements (93/42/EEC, 98/79/EC, 90/385/EEC) as well as new EU regulations 2017/745 und 2017/746.

  • Interactive collaboration with In-house experts covering all subjects related to CE-marking of medical devices /IVDs (pre-clinicians, clinicians, QM etc.) Implement and maintain regulatory SOPs within ISO 13485.

  • Close interaction with international clients as well as Notified Bodies and Competent Authorities.

  • Development of creative solutions in order to fulfil client needs combined with regulatory requirements.

 

Requirements

  • A degree in electrical, medical/biomedical engineering.

  • Experience in medical device or IVD industry, preferably in regulatory affairs and/or quality management related positions; Notified Body experience

  • Working knowledge of Electrical safety for medical device norm (IEC 60601)

  • Previous experience supporting international registrations to include 510k.

  • Working knowledge of ISO 14971 & IEC 62304.

 

If you are interested, please apply with your CV or email Kasia Krasuska on kasia.krasuska@adaptivelifescience.com or call her on +49 30 16 63 83 76.

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