Global Regulatory Affairs Manager

2 days ago


Ballerup, Ballerup Kommune, Denmark Demant Polska Full time

Job Summary

As our new Regulatory Manager, you will act as an operative consultant on all global projects. You will interact with our Danish R&D team and collaborate daily with our dedicated project managers and their teams in China. Additionally, you will be one of the primary interfaces to external approval authorities together with our regulatory team in Poland.

Your Key Responsibilities

  1. Monitor and interpret new legislation that can impact our business
  2. Maintain and develop relationships with our global network of external approval houses
  3. Act as the crucial link between development projects and regulatory requirements from global authorities
  4. Monitor and report new regulatory initiatives to relevant engineers, developing and optimizing regulatory compliance processes, and maintaining our database of technical documentation are key aspects of this role
  5. Scope and drive projects for optimization of business processes related to regulatory affairs
  6. Manage global certification processes to obtain and maintain product approvals worldwide
  7. Participate in tenders and internal/external audits
  8. Set direction for the company and be a regulatory mentor and coach for employees
  9. Budgeting, planning, and follow-up
  10. You will report to the Director, Supply Chain Management


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