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Regulatory Affairs Manager – Medical Device

  • Location:
  • Salary:
    £70,000 - £95,000
  • Job type:
    Permanent
  • Posted:
    4 months ago
  • Category:
    Regulatory Affairs
  • Deadline:
    November 28, 2018
  • Languages:
    English, German

Regulatory Affairs Manager – Medical Device

A top global medical device company in Germany are looking to expand their regulatory team. This is an opportunity for an experienced manager to join and to be part of an organisation that is recognised, globally, and well-respected as a leader within the Medical Device area.

With a presence for over 100 years, this organisation is dedicated to providing the best products to satisfy their customers’ needs. They have been stable, well-funded and experienced steady growth for over a century. As a result, they are seen as one of the top most stable companies to work for.

As a Manager of Regulatory Affairs, your responsibilities will include:

  • Being the lead in the product risk management team
  • Effectively supporting the commercialisation tasks for new products
  • Developing and executing global regulatory strategies for new and life-cycle of medical device
  • Assessing the regulatory risks and issues
  • Organising and making changes to the regulatory management
  • Structuring and developing the regulatory team
  • Representing the team to the supervisory boards
  • Participating with the implementation of regulatory strategy and requirements
  • Meet with and present the team in meetings with regulatory agencies
  • Maintain and keep up to date with new emerging and changing regulations
  • Help to mentor, train and develop lower level staff

To become a Manager of Regulatory Affairs, you must meet the following criteria:

  • 5+ years’ experience with Class III medical devices
  • BSc/MSc in a related field (i.e. biology/chemistry)
  • Previous experience with medical devices drug combination products
  • Strong knowledge on risk management according to EN ISO 14971
  • Strong knowledge of EU regulations/guidelines
  • Experience meeting and negotiating with regulatory authorities
  • Strong communicator

If you would like to apply or find out more about this opportunity, then please email:

alexander@al2s3.com

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