Regulatory Affairs Specialist

1 week ago


Stirling, Stirling, United Kingdom Cpl Life Sciences Full time

Reference Number:

JO
Regulatory Affairs Specialist - Medical Devices

Rate:
Negotiable

Job Type:
Permanent

Location:
Stirling

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


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.

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