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Rubicon Technical : Regulatory Affairs Specialist (Medical Devices)

Role: Regulatory Affairs Specialist (Medical Devices)

  • Location: Hull, United Kingdom

  • Salary: £32,000 - £37,000

  • Contract Type: Permanent Full-Time

Rubicon Technical is a technical service provider to the consumer healthcare industry. We work with medicines, medical devices, food supplements, cosmetics, and functional foods, providing expertise in regulatory affairs, medical affairs, development and formulation, clinical nutrition, pharmacology, trade marking, quality management, project management and artwork and pack copy. 

Rubicon Technical is a solution driven business. Our skilled team of consultants pride themselves on 'thinking outside the box' and are responsible for providing a range of bespoke technical services to the pharmaceutical, nutraceutical, medical device and cosmetic industries. 

Regulatory Affairs Specialist Role:

This is a fast-paced and incredibly varied role by nature of being a consultancy. The day-to-day requirements of the job will change constantly. Rubicon’s clients range from small, localised businesses to large multinational consumer health companies. This invaluable experience will develop your professional network and give you industry experience that is unrivalled. Your responsibilities would include, but are not limited to, the following:

  • Authoring technical/submission documents for various classifications of medical devices and IVDs

  • Prepare regulatory submissions for UKCA and CE conformity assessment. 

  • Provide expert guidance and support to clients on EU MDR and IVDR transition.

  • Provide expert guidance and support to clients on UK’s new medical device framework.

  • Conduct compliance reviews of technical files to ensure compliance throughout the product lifecycle.

  • Stay up to date on industry trends and regulatory changes to provide the best possible support to our clients.

  • Responsible for med device regulatory intelligence. 

  • Communicate effectively with both internal and external stakeholders to ensure a smooth and successful compliance process.

Requirements:

  • Relevant degree in Science, Maths or Engineering

  • 2-3 years’ experience within Regulatory Affairs within medical devices

  • Working knowledge of applicable domestic and international guidelines, policies and regulation

  • Knowledge and experience with pre- & post-market medical device regulations

The Rewards:

  • Pension 

  • Private healthcare 

  • Employee discount scheme  

  • Flexible working 

  • Death in service 

  • Employer supported volunteering days

  • Wellbeing days