Experienced Regulatory Affairs Specialist required for a Medical Device company in Wexford.
I am recruiting for an experienced Regulatory Affairs Specialist; this role is with a global medical technology company and operate within the medical device field. This is a permanent position and is based in Wexford.
Are you experienced with 510K submissions? CE mark and MDR? If you are, then this role is suitable for you!
Let me tell you more about the role:
You will support operations with all product development and quality to ensure the product is compliant with all internal and external regulatory requirements.
Some daily duties will include:
- 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 update 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.
Education & Experience required:
- Minimum 3rd level Degree in Science or equivalent
- Regulatory experience in: 510K RA related experience. You will have knowledge of U.S. and/or European regulations and standards covering medical devices
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.