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Biocompatibility Specialist (m/f/d)

Biocompatibility Specialist (m/f/d), 1. imageBiocompatibility Specialist (m/f/d), 2. imageBiocompatibility Specialist (m/f/d), 3. image

Discover Medi-Globe. Discover Innovation.

The Medi-Globe Group is an innovative, fast-growing and internationally oriented group of companies in medical technology in the field of urology and gastroenterology. Our four brands Urotech GmbH, Urovision GmbH, Medi-Globe GmbH and Endo-Flex GmbH have been developing, producing and marketing innovative instruments with excellent functionality for more than 35 years, enabling doctors to perform endoscopic procedures as precisely and successfully as possible.
 
Together with over 670 employees, we are driven by the spirit of innovation - and together we create solutions: from the idea to the market-ready product. Become part of our team, experience the fascination of our industry and actively contribute to the success of the Medi-Globe Group yourself.

YOUR CHALLANGE:

  • Plan and commission biocompatibility tests and create biological evaluations according to EN ISO 10993
  • Cooperate with various departments, especially Research & Development and Product Management, in the field of biocompatibility of medical devices
  • Support product registrations at home and abroad, develop biocompatibility strategies, and respond to inquiries from national authorities such as FDA, PMDA, EU, and NMPA
  • Assist in the implementation of product changes and new requirements from updated standards in the EN ISO 10993 series
  • Independently maintain, update, and provide technical documentation of medical devices and ensure compliance with regulatory requirements according to VO (EU) 2017/745 (MDR) and EN ISO 13485
  • Support audits conducted by the notified body

YOUR QUALIFICATION:

  • Ideally, a successfully completed degree in natural sciences (biology, biochemistry, etc.) or a relevant completed education and professional experience with preclinical testing procedures and the evaluation of medical devices
  • Good knowledge of standards and laws such as EN ISO 13485:2016, VO (EU) 2017/745 (MDR) and EN ISO 10993
  • Fluent English skills, both written and spoken
  • Strong quality awareness and technical understanding
  • Independent, responsible, structured, and precise working style
  • Enjoyment of teamwork and solution-oriented work
  • Flexibility in thinking and curiosity for new challenges

YOUR OFFER:

  • A permanent employment contract with attractive remuneration
  • Intensive training in all areas of responsibility 
  • 40% home office share - days freely selectable
  • A strongly growing and successful group of companies
  • A dynamic working environment in a committed team that attaches great importance to teamwork
  • Flat hierarchies, direct communication and short decision-making channels
  • Company pension scheme
  • Company events, (summer party, Christmas party, autumn festival visit etc.)
  • Free drinks, coffee and fruit
  • Health promotion (JobRad, EGYM Wellpass)

YOUR CONTACT:

Laura Strell
HR Manager
Medi-Globe-Straße 1-5
83101 Achenmühle