Regulatory Affairs/ Senior Regulatory Affairs Specialist
My client, an established Medical device organisation, is currently seeking a Regulatory Affairs/ Senior Regulatory Affairs Specialist to join their team on a permanent basis. This position will report into the regulatory affairs manager.
- Implementation of regulatory requirement in accordance with ISO13485, FDA 21CFR Part 820 and other relevant bodies
- Plans and prepares regulatory submissions, product changes and re-registrations and Reviews submissions
- Communicate the status of the regulatory requirements to the senior leadership team
- Work with the clinical team to ensure products requirements are met
- Work closely with other teams to ensure that regulatory requirements are met
- Mentors other team members
- Degree in Quality, Science or a related field
- 3+ year’s experience (5+ years for Senior) in a regulated environment
- Knowledge of medical device quality standards/practices or similar regulated industry
- Problem solving and organisation skills
Please note: If you are an EU/EEA national, you will be asked to show proof of right to work in Ireland e.g. showing your employer a copy of your passport.
If you are a non-EU/EEA national, you will require current and valid permission to work and reside in the Republic of Ireland. Information on legislation and guides to the procedures in relation to obtaining Green Card Permits, Work Permits, Spousal/Dependent Permits is available on the Department of Jobs, Enterprise, and Innovation website.