Regulatory Affairs Specialist

5 days ago

London, Greater London, United Kingdom Cpl Healthcare Full time

Senior Regulatory Affairs Specialist – Medical Devices & IVD's

Oxfordshire, UK – Office based

Up to £60,000 + benefits

This is an excellent opportunity to join a leading medical device manufacturing company that is the world leader in Glucose Monitoring. Their diverse product portfolio develops and manufactures glucose monitoring systems for use in both home and hospital settings.

With a global network serving customers in more than 160 countries, the organisation creates innovative solutions across the spectrum of health, for all stages of life. Whether it's next-generation diagnostics, life-changing devices, or science-based nutrition, the business is advancing some of the most revolutionary technologies in healthcare.

The business currently has one open position as a Senior Regulatory Affairs Specialist who will be responsible for planning, creating, and implementing solutions for regulatory registration and release of products for distribution into specific geographies.

  • Develop regulatory strategies while working cross-functionally with other departments.
  • Provide training and mentoring to junior colleagues, with scope for line management depending on individual preference.

Requirements:

  1. University degree in a scientific subject, such as Biomedical Science, Chemistry, Pharmacy, Engineering, or equivalent experience.
  2. Experience working within the requirements of ISO 13485, the Medical Devices Directive (93/42/EEC), and/or the IVD Directive (98/79/EC).
  3. Minimum of 4 to 5 years post-qualification experience in regulatory affairs, quality, or R&D in the medical device and/or pharmaceutical industry, specifically in product registration, medical device files, and/or technical compliance activities.

Due to the organisation's rapid growth, there is extensive opportunity to grow and develop within the company. In addition to a competitive salary, the organisation offers a highly attractive benefits package including a defined-contribution pension scheme, a share ownership scheme, private healthcare, life assurance, and a flexible benefits scheme that can be tailored to individual requirements.

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