BYTEC Medizintechnik GmbH

New position PRRC at BYTEC

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Aug. 31, 2021

In order to ensure our regulatory compliance - i.e. the adherence to all legal requirements as well as internal guidelines - we have expanded the previous position of Regulatory Affairs Manager to a Person Responsible for Regulatory Compliance.

This is a staff position in the company that is independent of all departments in order to have a neutral view of regulatory compliance in the company and reports to the CEO.

Tasks and objectives include:

  • Accompanying & monitoring development projects to ensure compliance to the development process and the preparation of required documents according to the QM system in time and quality.
  • Establish a compliance policy within the company to determine the level of compliance required and assess its risks.
  • Initiating and supporting the adaptation/creation of new procedures, work instructions and forms to optimize the processes and approval of the products.