Regulatory Specilaist (379433/001) München
Job Type: Regulatory Affair Specialist Location: Munich
A global leader in the innovative medical device industry, paving the way in discovering treatments seeking for a Regulatory Affairs Specialist to join their team. You can have a positive impact on the lives of millions of people around the globe who rely on their innovative for hope.Key Responsibilities:
- Support of EU as well as international product registrations
- Contact person for Distributors
- Notified Bodies and Competent Authorities regarding product approvals
- Maintain “Technical File” of company products according to MDD 93/42 EEC
- Support maintenance of Regulatory Affairs data base
- Regulatory support for TPV’s Program Electrical Medical System
- Risk management according to ISO 14971
Key Requirements Include:
- Bachelor or equivalent degree with a scientific or engineering background (FH / Univ.)
- At least 2-year experience in regulatory affairs of medical devices; Experience in minimum one of the following fields is required:
- According to DIN EN 62366
- Risk management according to EN ISO 14971:2012
Fluent English and German
Good communication skills
Benefits:
- Competitive benefits and great personal development opportunities
- Great atmosphere within a vibrant international team
- Insurance, Health & Wellness
- Learning & Development Support
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