Your career opportunity in medical technology

ACL is a strongly growing, medium-size business with headquarters in Leipzig, Germany. Since 1997, it has developed top-of-the-line imaging hardware solutions for medical diagnostics. The innovative products sold worldwide are constantly being further developed to meet the high demands of the medical sector. This will enable the company to continue to thrive in the market as one of the leading manufacturers of imaging hardware solutions for medical diagnostics.

To strengthen our team in Wachau/Markkleeberg near Leipzig, we are looking for committed employees willing to start immediately. We offer you:

  • varied tasks and projects in a globally active company
  • wide range of opportunities for further development
  • permanent position
  • open, collegial working atmosphere and teamevents
  • company retirement provisions

  • Regulatory Affairs employee (m/f/x)

    Your responsibilities:

    • Development of the concept for technical documentation and monitoring of the implementation
    • Development and maintenance of accompanying documents for ACL products
    • Determination of regulatory requirements for products and processes from standards, guidelines, laws and comparable sources and support during implementation
    • Internal conformity assessments for ACL products
    • Coordination and control of certification activities and laboratory tests on products, support of notified bodies and testing laboratories during product testing
    • Monitoring and control of test marks and the resulting requirements
    • Obtaining marketing authorisations worldwide
    • Market approval and monitoring of medical devices according to MDR
    • Implementation of the requirements according to ISO 60601
    • Together with the project management: Regulatory integration of ACL products into the products of OEM partners as well as consulting
    • Together with strategic purchasing: consulting, documentation and monitoring of supplier parts with the supplier from a regulatory perspective, both with regard to the integration of their products into ACL products and the necessary processes

    Your profile:

    • University degree with technical background, e.g. medical technology, or proof of sufficient knowledge in the field of medical device testing and market approval or related courses
    • Independence, initiative, sociability, result-oriented attitude to work

If the ability to work in a team, a sense of duty, flexibility and reliability are important factors in your daily work, we look forward to receiving your detailed application by e-mail sent to personal@acl.de or by post to:

ACL GmbH
Personalabteilung
Apelsteinallee 5
04416 Markkleeberg