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- Assist in the production and review of design dossiers technical files, and Product Approval Certificates.
- Preparation of regulatory submission for product approvals.
- Preparation of Custom Made device, Special Products paperwork and change assessments.
- Participate in Design Control, Risk Management, Post Market Surveillance and document changes.
- Facilitate compliance with Vigilance System.
- Update and review all IFU, Packaging and Labelling
- Other duties as required by Regulatory Affairs department
- BSc Hons Degree or equivalent.
- Regulatory experience within a medical device or pharmaceutical environment is desirable.
- Class 3 Medical device experience preferred
Senior Regulatory Affairs Associate - Inchinnan, United Kingdom - Terumo Aortic
Description
Terumo Aortic are looking for a Senior Regulatory Affairs Associate to join our team during an exciting time of growth and expansion for the business. This is a fantastic opportunity for someone to join our Regulatory Affairs team in a rewarding role with a company that offers career development amongst a host of excellent benefits.
Key Duties :-
Qualifications & Experience :-
This role can be remote based with occasional travel to our Glasgow site.