Senior Regulatory Specialist
CK Science are currently recruiting for a Senior Regulatory Specialist to join a global Biotechnology company based in Abingdon on a permanent basis. The successful candidate will lead and support all Pre and Post Market activities for IVD and Medical Device products
Salary: On offer is a competitive salary plus benefits (pension, life assurance and 25 days holiday plus bank holidays).
The Role: Responsibilities of the Senior Regulatory Specialist:
- Provide regulatory support and guidance for all regulated products (Pre and Post Market).
- Maintain and update technical files for product modifications.
- Compile and publish all material required for submissions, license renewals, and annual registrations.
- Provide input to global registration and device listing.
- Bachelor's Degree in related field.
- Commercial experience (minimum five years) in Regulatory Affairs within the IVD or Medical Device industry.
- Understanding of new IVDR and MDR requirements.
- Understanding of US regulatory pathways such as 510(k)'s or PMA.
- Experience in foreign regulations and dossiers compilations including US submissions (HIGHLY DESIRABLE).
Apply: For more information or to apply for this Senior Regulatory Specialist position, please contact Naynesh Mistry on 01246 457722 or email firstname.lastname@example.org, quoting job ref 48523.
It is essential that applicants hold entitlement to work in the UK.