Senior Regulatory Affairs Associate

Apodi Limited

2018-08-02 14:00:00

Job location Stokenchurch, Buckinghamshire, United Kingdom

Job type: fulltime

Job industry: Government & Defence

Job description

Job Description

Our client, a healthcare company who are a specialist in their field have an exciting opportunity for a Senior Regulatory Affairs Associate to join their growing business.

Your role will be to support and expertise by developing EMEA regulatory strategies and submissions. You will support Global Regulatory Affairs in creation and maintenance of regulatory intelligence reports, essential requirement checklists, technical files and declarations of conformity of CE Marking.

  • Responsibilities and duties include but not limited to;
  • Providing regulatory advice and support to the business locally and the EMEA region
  • Liaison with regulatory agencies and notified bodies regarding regulatory matters,
  • Plan and organise registration submissions to regulatory agencies, preparation of registration packs in line with European Union or EMEA regulatory requirements and guidelines.
  • Evaluates product, process and any label changes for regulatory impact
  • Responsible for regulatory approval as part of sales enablement of product for EU Distribution.
  • Evaluate applicability of regulations and able to develop and document a robust regulatory position

You will have done a similar role previously and will have sound knowledge and awareness of regulations applicable to the devices industry in the EMEA region. You will be able to review, evaluate and summarise technical data along with the ability to communicate complex information to your peers and regulatory bodies.
Good package on offer with a stable growing company. If you think this sounds like you then PLEASE APPLY NOW!

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