Regulatory Affairs Specialist
Amazing RA opportunity to join a world-renowned Medical Device organization in Wexford, the ''Sunny South East'' of Ireland!
Our Client is currently in expansion mode with a number of exciting NPI products being introduced to the site. They currently have a requirement for a RA Specialist, who will be a key member of the RA Team with responsibility for regulatory support for operations, product development and quality to ensure that the product is in compliance with all internal and external regulatory requirements
What is in it for you?
- This is great opportunity to expand your skillset in this fast moving, dynamic and agile business.
- Attractive salary and benefits package on offer together with a friendly, welcoming and collaborative working environment
- Days role, flexitime available & half day on a Friday!
- Onsite parking and canteen
- Commutable distance from Kilkenny, Waterford, Tipperary or Wicklow.
You will be degree qualified with relevant experience in RA within the Medical Devices Industry
- 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.
- Third level degree preferably in science or business.
- Minimum 3 years RA related experience in Medical Devices an absolute requirement
- Knowledge of U.S. and/or European regulations and standards covering medical devices
- 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.