Description
y client, based in Cork, is seeking an RA officer with 2 years of experience, in a regulated environment, preferably medical devices. This position is a fantastic opportunity to gain great experience for an exciting6 month contract.Responsibilities:
- Coordination and management of regulatory and product registration activities following recent
- Responsible for providing RA input for projects in a timely manner
- Preparation of internal reports and change control documents, and the review of documents for potential impact on global regulatory submissions.
- Participation in project work such as new product introductions, changes to existing products and processes, and other regulatory/company projects as required.
-Generate supporting design documentation risk analyses and essential requirements checklists by working with cross functional teams and across sites to support technical files completion.
- Monitor international standards and regulations and maintain standard/regulation implementation plan for site.
- Preparation of information to support Product Tender Applications in the international markets
- Preparation of regulatory documentation to support customer services with the shipment of products
- Support Notified Body, FDA and international regulatory agency audits
- Support maintenance of product registration database
-Review and evaluate technical and scientific data and reports and incorporate them into documents for submission to the EU, FDA and foreign regulatory agencies
-Ensure local site regulatory procedures are aligned with corporate procedures.
- Pursue relevant information pertaining to new developments in regulatory affairs
Requirements
- Degree level life sciences, engineering or scientific qualification
- 2 years minimum Quality system or regulatory experience in the medical industry
- Project management skills and leadership ability
- Experience in the preparation and submission of Registration Files, Design Dossiers and Technical Files
- Excellent interpersonal skills and ability to work with people from different cultural backgrounds to achieve results.
- Excellent written and communication skills
This is an urgent requirement interviews will take place immediately. If you are interested in this 6 month contract and have the relevant skills and experience please contact me Anna Mooney , or apply below with an updated CV.
To find out more about Real please visit www.realstaffing.com