Regulatory Affairs Specialist

Posted 7 June by Langton Howarth Ltd
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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 Specialistyou will havetwo + 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 License

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

Required skills

  • Microbiology
  • Regulatory Affairs
  • Regulatory Requirements
  • Technical Documentation
  • IVD

Reference: 38159712

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