Regulatory Affairs Associate - Renfrew, United Kingdom - Terumo Aortic

Terumo Aortic
Terumo Aortic
Verified Company
Renfrew, United Kingdom

1 week ago

Tom O´Connor

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Tom O´Connor

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Description

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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.

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- **Key Duties:

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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
- **Qualifications & Experience:

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  • 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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