Global Senior Regulatory Compliance Expert in Medical Devices

2 weeks ago


Copenhagen, Copenhagen, Denmark WSAudiology Full time

WS Audiology is at the forefront of the medical device industry, navigating a rapidly evolving regulatory landscape.

As a pivotal role in our company, we're seeking a Global Senior Regulatory Affairs Specialist to join our team.

In this HQ-based position, you will be integral to ensuring that our products meet the highest standards of compliance.

Your mission will be to provide expert guidance and support, ensuring that our regulatory strategies are robust, and our compliance standards are upheld.

Reporting directly to the Senior Director of Global Regulatory Affairs, you'll play a crucial role in steering our regulatory affairs practices through this exciting transformation.

Key Responsibilities:
  • Serve as a primary knowledge resource for EU MDR, US FDA 21 CFR 820, and ISO 13485, with deep expertise in areas such as Technical Documentation requirements
  • Lead Regulatory Affairs problem-solving initiatives and manage regulatory projects from concept to completion
  • Provide expert guidance to the global organization on Classification, Intended Use, labeling requirements, and the Declaration of Conformity for hearing instruments, medical apps, and related accessories
  • Act as the Subject Matter Expert (SME) on Regulatory Affairs during audits and inspections, ensuring compliance and addressing any regulatory concerns.
  • Manage CAPA processes related to Regulatory Affairs, ensuring timely and effective resolution of issues
  • Contribute to the development and execution of the Global Regulatory Affairs strategy, driving continuous improvement and regulatory excellence

The ideal candidate has a proven track record as a Global Senior Regulatory Affairs Specialist and Project Lead in a complex organization, with demonstrated success in embedding a strong compliance culture throughout the entire organization.



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