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Regulatory Affairs Engineer

Canary Wharf, London, £Competitive + benefits and bonus
Permanent
Reference: RC8072

Regulatory Affairs Engineer required by medical devices leader. This role will see you working as part of the European team to support the global delivery of its products in a regulated environment. You will work closely with business areas including manufacturing and supply chain, research and development and engineering. You will liaison with regulatory authorities. This is a high impact role that works in a fast paced dynamic environment and makes a meaningful contribution to our client's business.


Key Responsibilities:

  • Provide guidance on product regulation and translate into meaningful business requirements
  • Gain market access for our regulated products including submissions
  • Communicate with regional and business teams and prepare responses on all governing agency actions
  • Review promotional labelling
  • Represent regulatory affairs in new product development as well as maintenance projects
  • Participate in product release process
  • Participate in regulatory process improvements work



Key Requirements: 

  • Solid experience in Regulatory Affairs.
  • Experience working with manufacturing or product development, preferably in the MedTech or Pharma industry.
  • We value experience from working with quality assurance, compliance issues and experience from working with internal and external audits.
  • Master of Science degree (Mechanical, Electrical, Industrial Engineering, etc.) or equivalent engineering degree.



For a full consultation on this role please email your CV to Arc IT Recruitment.

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