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Team Leader - Regulatory Affairs, Inchinnan
Client:
Location: Inchinnan, United Kingdom
Job Category: Other
EU work permit required: Yes
Job Reference: a8ac8a04c73e
Job Views: 7
Posted: 26.04.2025
Expiry Date: 10.06.2025
Job Description:
Terumo Aortic is seeking a Regulatory Affairs Team Leader to join during an exciting period of growth and expansion. This role offers an excellent opportunity for career development within a company that provides many benefits.
Key Duties:
1. Preparation and review of regulatory documentation and submissions for product approval.
2. Development of regulatory plans and strategies for new and existing products.
3. Participation in Design Control, Risk Management, and Post Market Surveillance activities.
4. Production and review of design dossiers, technical files, and change assessments.
5. Review and preparation of regulatory paperwork in line with international standards and new regulations.
6. Review of product packaging, labelling, Instructions for Use (IFUs), and marketing literature for compliance with country-specific regulations.
7. Facilitate compliance with Vigilance System.
8. Provide regulatory input to various functional groups.
9. Participate in reviewing RA procedures.
10. Review and approve validation protocols and reports.
11. Mentor RA Associates.
12. Perform other duties as required by the Regulatory Affairs department.
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