Regulatory Affairs Associate - Renfrew, 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:
- **_
- 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.
Job Types:
Full-time, Permanent
Benefits:
- Additional leave
- Company pension
- Cycle to work scheme
- Discounted or free food
- Free parking
- Life insurance
- Onsite parking
- Sick pay
- Work from home
Schedule:
- Monday to Friday
Supplemental pay types:
- Bonus scheme
Work Location:
Hybrid remote in RENFREW
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