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.
Responsibilities
· 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.
Requirements
· 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 2 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 [email protected]
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.