Regulatory Affairs Specialist
Vor 2 Tagen
Aristo Group is a leading project and personnel consulting firm specializing in the life science industry. Our mission is to find the perfect match for our clients and candidates.
We are currently seeking a highly skilled Regulatory Affairs Specialist (m/w/d) for our office in Hannover, Germany.
About the JobThe successful candidate will be responsible for executing and assisting medical device registration for EMEA and China, as well as internal regulatory review processes to ensure compliance with the Medical Devices Regulation (MDR). Key tasks include:
- Executing and improving internal records systems, particularly regulatory files (Technical File according to MDR Annex II & III or STED)
- Assisting in SOP development, review, and implementation
- Evaluating regulatory history, guidelines, policies, and regulations specific to products and markets
- SUPPORTING THE DEVELOPMENT OF REGULATORY STRATEGY AND UPDATE BASED ON REGULATORY CHANGES
The ideal candidate will possess a Dipl.-lng./Bachelor's degree (BS) in Engineering, Physics, Chemistry, Biology, or a related discipline, with at least 3 years of experience in medical device regulation. Strong knowledge of international regulations and standards, including MDD and/or MDR, ISO 13485, and MEDDEV 2.12/1, is also required.
In return, you can expect a competitive salary of around €60,000 per year, depending on experience, plus additional benefits such as health insurance and a generous vacation package.
A fulfilling career awaits you with Aristo Group Join us and take the next step in your professional journey.
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