Regulatory Affairs Specialist

Location: Basingstoke, Hampshire Salary: £30000 - £40000 per annum
Sector: Quality Assurance (QA), R&D, Regulatory Affairs (RA) Type: Permanent

Our client is a market leading Medical Device and Pharmaceutical Company. The Regulatory Affairs Specialist is a role in the Microbiology Division's (MBD) Global Regulatory Affairs function. The primary purpose of this role is to assist with accelerating the Business's preparations to meet the requirements of the forthcoming IVD Regulation.

The role will encompass assessing existing technical documentation, assisting with defining a strategy to implement timely actions and compilation and inspection of technical information designed to keep our products in compliance with European Regulation. The Regulatory Affairs Associates will report to the Regulatory Affairs Manager.

  • Implement regulatory strategy across a wide portfolio of devices to ensure that company products are safe, legal and meet expectations for compliance with European regulations
  • Assess, report on and action any gaps in current technical information
  • Work closely with the Technical teams and Project Management to ensure timely delivery of goals
  • Generate records and documentation for inclusion into device-supporting Technical information
  • Collaborate and assist with the digitization project to enable faster access to legacy information


  • Degree or related work experience
  • Regulatory exposure within the IVD or medical device industry

Preferred Skills:

  • Knowledge of IVD Directive
  • Ability to plan multiple tasks and effectively prioritize activities
  • Capability to drive assignments to completion
  • Effective communicator with management, peers and internal customers
  • Experience of working with active devices (IEC 60601, IEC 61010, IEC 62304) would be an advantage
  • Pro-active with proven ability to work under own initiative, and strong team player
  • Current full Driving License (ideally)

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