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(Junior) Regulatory Compliance Manager - Medical Devices (m/f/d)

(Junior) Regulatory Compliance Manager - Medical Devices (m/f/d), 1. image(Junior) Regulatory Compliance Manager - Medical Devices (m/f/d), 2. image(Junior) Regulatory Compliance Manager - Medical Devices (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:

  • Independent maintenance, updating, and provision of technical documentation for medical devices and ensuring compliance with regulatory requirements in accordance with Regulation (EU) 2017/745 (MDR) and EN ISO 13485:2016.
  • Maintenance and monitoring of the database on standards and norms.
  • Cooperation with various departments, especially Research & Development and Product Management.
  • Support during audits by the notified body.
  • Contribute to the implementation of product changes.
  • Support in product registrations domestically and internationally.
  • Processing and responding to test reports from the notified body.
  • Compilation of technical documentation for commissioning clinical evaluations.

YOUR QUALIFICATION:

  • Ideally, a successfully completed technical degree or relevant completed training and professional experience in the technical or medical technology field
  • Good knowledge of standards and laws such as EN ISO 13485:2016, Regulation (EU) 2017/745 (MDR), and EN ISO 10993
  • Strong quality awareness and technical understanding
  • Enjoy working in a team and solution-oriented work
  • Good verbal expression - and good English skills in spoken and written
  • Flexible thinking and curiosity about new challenges
  • Independent, responsible, structured, and precise working method

YOUR OFFER:

  • A permanent employment contract with attractive remuneration
  • Intensive training in all areas of responsibility 
  • 40% remote work 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)

IHR KONTAKT: // YOUR CONTACT:

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