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Regulatory Affairs Specialist - Medical Devices

Stirling   •  Negotiable  •  Permanent, Full time

Regulatory Affairs Specialist – Medical devices

Stirling Scotland – Hybrid

I have an exciting opportunity to work as a Regulatory Affairs Specialist for a global leader in medical microwave technology, with a focus on radical innovation in the treatment of HPV infections, dermatology, cardiology, and oncology.

As a Regulatory Affairs Specialist, you will support the business’s growth by mainly being responsible for managing Medical Device regulatory submissions and regulatory compliance activities.


· Compile regulatory submissions, Technical Files for new products and changes to existing products & markets.

· Support new product development projects to provide ongoing regulatory guidance and ensure compliance with relevant regulatory requirements.

· Review labelling/marketing material for compliance with applicable regulations and standards.

· Support post-market surveillance and vigilance activities, including submitting reports to authorities.

· Review new and existing regulations, guidance documents & Standards, and prepare comments based on the impact on products and the business.


· Bachelor of Science Degree in biology or similar field, from an accredited college or university and a minimum of 2 years of Regulatory experience within a Medical Device or Pharmaceutical environment.

· International regulatory affairs experience with awareness of EU MDD/MDR, FDA, Heath Canada and other regional regulations.

This is a great opportunity for a junior regulatory affairs professional to step into a specialist position and gain further exposure in an advanced medical device business.

This role will be a hybrid position with 4 days of office work per week and the position will come with a generous salary, private healthcare, and a pension scheme.

If you are interested in this role or would like more details please email your CV to lucy.kirkaldy@cpl.com

Remember if this role is not suitable for you please feel free to forward this to anyone you feel would be suitable. If we successfully find a role for your recommendation we will give you £250 in vouchers of your choice.

  • Agency: Cpl Life Sciences
  • Reference: JO-2302-510889
  • Posted: 21st February 2023
  • Expires: 21st March 2023

Cpl Life Sciences

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