Senior Regulatory Affairs specialist

The Medical Device industry is facing constant changes within the legislative area, and particularly within the new Medical Device and IVD regulation during the next 3 to 5 years.

Would you like to be part of a skilled team helping a broad range of customers through the new, complex regulatory landscape?

Medicologic is a leading Danish medtech consultancy company. Together with our customers we bring new and innovative products on the market with focus on speed to market.

We are growing and thus need additional resources.

A challenging job with a broad variety of Regulatory assignments
With a strong pipeline of challenging projects, we are seeking a passionate Senior RA specialist to join our RA/QA team in Copenhagen. Reporting to the Team Manager you will be part of our RA/QA team and interact with customers to solve hands-on RA assignments.

Specifically your role will be:

  • Provide information and advice to customers on the regulatory procedure for medical devices
  • Establishment of regulatory strategy documenting the most suitable pathway for regulatory approval
  • Preparation, submission and management of Technical Files/Design Dossiers/FDA 510(k) and PMA applications in compliance with the requirements of the MDD/IVDD/FDA and the QMS
  • Function as a RA subject matter expert toward customers
  • Interaction with notified bodies and national health authorities
  • Documentation management and documentation reviews

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    Qualifications

  • Relevant education degree (B.Sc. or M.Sc.) or equivalent in relevant scientific discipline
  • Minimum +5 years of experience in relevant positions
  • Strong knowledge of Directives, Standards and Guidelines within the medical device industry – MDD/MDR/IVDD/IVDR/AIMD and FDA requirements
  • Having experience within International registration applications would be an advantage
  • Strong understanding of ISO13485, 21 CFR part 820, CMDCAS
  • Training and teaching experience is an advantage

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    As a person you are:

  • Structured and having an analytical and professional approach to work
  • Detail oriented and capable of digesting large amounts of complex data
  • Have a strong collaborative approach towards stakeholders
  • A good listener with strong communicative skills
  • Strong cultural awareness and a global mindset
  • Fluency in English
  • Outgoing personality with skills to facilitate and lead projects

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    Join a leading medtech consultancy
    Our customer-centric consulting approach will give you an insight into cutting edge medical device development both in Denmark and internationally. We offer a challenging environment with exciting opportunities. We are very ambitious and you will be an important player in helping us realize our growth plans.

    We look forward to welcoming you in our engaged, warm and professional environment with sparring from highly experienced experts as well as social events amongst colleagues. We wish the daily work experience to be a steady path towards professional as well as personal growth. Of course, we offer a competitive compensation package including pension and insurance.

    Contact information
    If you want to know more about the job you are welcome to contact CEO, Michael Funder on +45 20 64 41 46 or mf@medicologic.com

    Send your application
    Send your application including CV to mf@medicologic.com
    Since this is a priority position interviews will be conducted on an ongoing basis.

    We look forward to hearing from you.