Terumo Aortic are looking for a Regulatory Affairs Team Leader 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:-
1. Preparation and review of regulatory documentation and submissions for product approval.
2. Development of regulatory plans/strategies for new products and changes to 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 accordance with International standards and new regulations.
6. Review of product packaging, labelling, IFUs and marketing literature for compliance with specific country regulations.
7. Facilitate compliance with Vigilance System.
8. Provide regulatory input to functional groups as required.
9. Participate in review of RA procedures.
10. Review and approval of validation, protocols and reports.
11. Mentorship of RA Associates.
12. Other duties as required by Regulatory Affairs department.
Qualifications & Experience:-
13. BSc Hons Degree or equivalent.