Regulatory Affairs Specialist – Medical Devices

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Regulatory Affairs Specialist

Fridingen an der Donau

We are currently looking for a Regulatory Affairs Specialist – Medical Devices for a medium-sized family business in Fridingen, Germany. The company is characterized by its expertise and high-quality instruments, which are used in numerous specialist areas of surgery, high-tech devices and surgical system solutions in more than 70 countries.

 

Your position:

– Develop regulatory requirements, together with the RA Manager

– Preparation of biocompatibility assessments

– Creation and maintenance of the English technical documentation

– Regulatory management of development projects

– Interdisciplinary collaboration with the Development, Product, and quality management

 

Your profile:

– +3 years of experience within the medical device industry

– Experience in the preparation of biocompatibility assessments desirable

– Preparation of clinical evaluations desirable

– Affinity for technical documentation of medical devices

– Good knowledge of MDD 93/42/EC and MDR 2017/745

– Practical knowledge of the worldwide registration of medical devices desirable

– Ability to work in a team and organizational talent combined with economic thinking

– High degree of diligence

– Very good spoken and written in German and English

– Majesty / ELO experience

 

We offer you:

– Performance orientated pay and permanent employment contract

– Flexible working time model

– Home office

– Monthly €50 petrol card

– Free water, coffee, and apples

– Group accident insurance

– Modern, well-equipped workplace in bright premises

– Professional development, development opportunities and prospects

– Pleasant working atmosphere in a dynamic team

– Job bike (e-bike)

Contact

If you want to hear more about this opportunity and the company, or if you have any questions regarding the position, please do not hesitate to contact us. If you wish to apply for the position, please send an updated version of your CV, together with what questions you might have, and we will get in touch with you soon.

2022_08_12_BSE_Uta_Talkenberg_378

Uta Talkenberg-Rasmussen

Consultant

Talent Engagement

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* Please refrain from including your social security number (CPR no.) in your CV.