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.