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Details

Regulatory Affairs Specialist


Reference:CK/A006896 Location: Wexford
Qualification:DegreeExperience:1-2 Years
Job Type:PermanentSalary: Not Disclosed

RA Specialist
Our client, a respected medical device company are currently recruiting a RA Specialist who will be responsible for regulatory support for operations, product development and quality to ensure that the product is in compliance with all internal and external regulatory requirements.

As RA Specialist, you will:
Participate in product development/line extension teams as required to ensure that the product is in compliance with all internal and external regulatory requirements. Develops, documents and implements a regulatory submissions plan around product development/line extension goals.
Prepare U.S. FDA submissions (e.g., 510(k) US Submission for Medical Device Class 2 Device, IDE Requesting to do a clinical trial) as required and per applicable SOPs.
Prepare and updates European and international technical files/dossiers/registrations as required and per applicable SOPs.
Review Engineering Change Orders, Design Change Notices and other deviations for compliance with FDA, European and international regulations and standards.
Ensure adequate documentation compliance to FDA, European and international regulations and standards. Ensure continuous update and maintenance of the Regulatory Affairs files.
Develop working relationships with key personnel/representatives of the U.S. FDA Offices of Device Evaluation and Compliance and Notified Body.
Prepare and present project updates and technical discussions.

The successful candidate will be educated to third level degree preferably in science or business. You will have RA related experience. You will have knowledge of U.S. and/or European regulations and standards covering medical devices. You will be IT literate and adapt to new systems easily. You will have excellent written and oral communication skills coupled with your willingness to learn , help other team members, collaborate and support where needed. You will have attention to detail, be adaptable and embrace change.

You can look forward to a rewarding career, great benefits package, flexible hours, collaborative working and opportunities to expand your skills in this fast moving, dynamic and agile business
If you would like further Information you can contact the recruiter directly:

Claire Kenny | Tel: +353 (0) 1 507 9287