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.
- Preparation and review of regulatory documentation and submissions for product approval.
- Development of regulatory plans/strategies for new products and changes to existing products.
- Participation in Design Control, Risk Management and Post Market Surveillance activities.
- Production and review of design dossiers, technical files and change assessments.
- Review and preparation of regulatory paperwork in accordance with International standards and new regulations.
- Review of product packaging, labelling, IFUs and marketing literature for compliance with specific country regulations.
- Facilitate compliance with Vigilance System.
- Provide regulatory input to functional groups as required.
- Participate in review of RA procedures.
- Review and approval of validation, protocols and reports.
- Mentorship of RA Associates.
- Other duties as required by Regulatory Affairs department.
Qualifications & Experience:-
- BSc Hons Degree or equivalent.
- 3-5 years regulatory experience within a medical device environment is essential.