Regulatory Affairs Manager
Salary/Rate:80,000EUR
Job type:Perm
Town/City:Greater Freiburg Area
Country:Germany
Business Sectors:Regulatory Affairs
Job ref:24817
Post Date:15. 12. 2023
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About the Role
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 Dominika Wyrwinska on dominika.wyrwinska@adaptivelifescience.com..
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