Regulatory Affairs Specialist - Stirling, United Kingdom - Cpl Life Sciences

Cpl Life Sciences

Verified Company

Stirling, United Kingdom

3 days ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

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.