Posted 3 months ago

Regulatory Affairs Specialist

Salary: Negotiable + Pension + Private Healthcare + Life Insurance + 25 days holidays + 8 bank holidays + Much more!

Location: Site based in either Basingstoke, East Grinstead, or Dartford, Kent

The requirements of the Regulatory Affairs Specialist:

  • To be considered for the role of Regulatory Affairs Specialist you will have two + years’ experience within the IVD or medical device industry in a regulatory affairs role
  • You will have a Degree (BSc or MSc) or HND in Science, Life Sciences or Engineering
  • Excellent IT skills
  • Knowledge of IVD Directive
  • Excellent attention to detail
  • Ability to plan multiple tasks and effectively prioritize activities
  • Capability to drive assignments to completion
  • RAC accreditation is preferred
  • 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 Licence

The role of the Regulatory Affairs Specialist:

  • As the Regulatory Affairs Specialist you will work within my client’s Microbiology Division’s (MBD) Global Regulatory Affairs function to 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
  • 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
  • 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 digitisation project to enable faster access to legacy information

The Company:

  • My client is a true market leader across the life sciences sector
  • Their product range is vast and un-rivalled within the industry not only for its broad range but the true quality of the products which they offer
  • With particular focus on customer satisfaction, they retain business at an extremely high rate and have a firm majority of the market share in a variety of markets as a result

Apply today by sending your CV to Oliver Gill of Langton Howarth Ltd via email to or call Oliver in confidence right now for more information on 0113 243 3499 OR 07792 488 206.

You must have the right to work in the UK to be considered for this role

Langton Howarth also operates a recommend a friend referral scheme. So, if you know someone who could be good for this job, email your nominated candidate’s name and contact details in confidence via email too, and we’ll ensure you receive £100.00 of vouchers from a high street retailer of your choice once we have successfully placed the person referred by you.

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