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Regulatory Affairs Expert

2 months ago

Copenhagen, Copenhagen, Denmark WSAudiology Full time

At WSAudiology, we're navigating a rapidly evolving regulatory landscape, and we're looking for a Global Senior Regulatory Affairs Specialist to join our team.

This HQ-based position will be integral to ensuring that WSAudiology products meet the highest standards of compliance. Your role will be central to our day-to-day regulatory problem-solving and will involve active collaboration with our global Regulatory Affairs team and other key stakeholders across the organization.

Your mission will be to provide expert guidance and support, ensuring that our regulatory strategies are robust, and our compliance standards are upheld. You'll manage interactions with both HQ and global stakeholders while building confidence in the advice and support you offer.

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

Candidate Profile:

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. Additionally, you are likely to possess:

  • A relevant MSc degree in Engineering, Natural Science or Technology
  • +5 years of experience of working as an RA professional of medical devices in EU and the US
  • Experience with optimization of global/international regulatory affairs processes
  • Experience in interacting with regulatory authorities
  • Thorough knowledge of medical device regulation; EU MDR, US FDA 21 CFR 820, and ISO 13485
  • Interest in learning about the Radio Equipment Directive (2014/53/EU) and Global Radio Equipment requirements for Medical Devices.

Personal Competencies:

  • A results-driven mindset with a deep commitment to delivering on promises and meticulous attention to detail
  • The ability to interpret and enforce regulatory requirements pragmatically and effectively
  • A dedication to compliance, consistently seeking opportunities to enhance and promote regulatory adherence
  • Excellent interpersonal and intercultural communication skills, enabling effective collaboration with global colleagues and stakeholders
  • Professional-level proficiency in English, both written and spoken