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?
Our client – a well-established Consultancy is currently looking for a Regulatory Affairs Expert to strengthen their international team.
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.
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 email@example.com or call her on +49 30 16 63 83 76.