Regulatory Affairs Manager

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Regulatory Affairs Manager

Humlebæk

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You will become an expert on one of our product groups, e.g. Ostomy Care, Continence Care or Wound Care. You will be involved in change projects where you use your regulatory knowledge to evaluate and communicate the impact of changes to product components.

You will be working on multiple projects in close collaboration with specialists in marketing, clinical operations, supply chain and R&D, as well as our subsidiaries. To do so, you need to be comfortable communicating, coordinating and collaborating across functions and cultures, applying your proactive mind-set to plan, execute and meet deadlines.

You will:

Participate in cross-functional projects for product modifications to ensure regulatory compliance
Prepare regulatory files, clarify procedures and create or approve relevant documentation
Communicate regulatory requirements across Coloplast