Regulatory Affairs Associate

2 weeks ago

Inchinnan, United Kingdom Terumo Full time

**Permanent**

**Regulatory Affairs Associate**

**Inchinnan**

**Competitive + Bonus + Benefits**

**_Terumo Aortic are looking for a Regulatory Affairs Associate to join our team on a fixed term contract 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:

- _**
- 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

**_Qualifications & Experience:

- _**
- BSc Hons Degree or equivalent.
- Regulatory experience within a medical device or pharmaceutical environment is desirable.

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