Regulatory Affairs Specialist

Regulatory Affairs Specialist
Our client a multinational medical device company currently seeks a Reg Affairs Specialist to join their team. Successful candidate will be required to work in the Regulatory Affairs area to ensure that the area runs in a smooth and efficient manner. Function will involve a thorough understanding of both the clinical trial and regulatory requirements required for the Medical Device Industry.

Role/Responsibilities:

• Responsibility for structuring and managing technical files.


• Responsibility for implementing regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA QSP 21CFR Part 820


• Responsibility for product registration in the EMEA, and other markets as appropriate.


• Responsibility for registration of all Class I devices with the Irish Medicines Board.


• Member of the new product introduction and design control teams.


• Liaison with the Notified Body and other relevant authorities.


• Responsibility for handling regulatory affairs related queries.


• Responsibility for ensuring that device labelling is correct and that they meet regulatory requirements.


• Responsibility for review and approval of validation and verification documents from a regulatory view point

Skill/Experience

• Third level Qualification in Science/Quality, at least 5 years experience in a regulated industry in a similar role.


• Thorough knowledge of the EU, MDD and EMEA requirements.


• Thorough knowledge of the RA requirements in the GHTF countries.


• Knowledge of medical device quality standards/practises or similar regulated industry


• Good communication and inter-personal skills.


• Proven problem-solving skills.


• Good computer skills including knowledge of Microsoft® Office.


• Proven organisational skills.


• High self-motivation.


• Approved External Auditor.


• Willingness to travel on company business

If you would like further Information you can contact the recruiter directly:

James Cassidy | Tel: +353 (0) 1 5079250