Our client, a medical device company in Cork is currently looking to recruit a Regulatory Affairs Specialist II for their site.
Responsible for Regulatory Affairs support of the product development process, submissions and regulatory compliance.
- Working as part of a team responsible for regulatory activities and issues occurring in the company. Includes review of Technical Files and providing information to US International Regulatory Affairs groups for other submission activities as well as regulatory issues relating to labelling, releases, and change orders.
- Assist in preparation of Design Dossiers/Technical Files for all the products, in conjunction with divisional personnel and QA personnel.
- Review and approve documentation related to product release.
- Provide input, review and approve facility regulatory activities such as labelling.
- Provide Emerging Markets submissions information to U.S. based and Emerging Markets based International Regulatory Affairs personnel for all products.
- Provide updates on regulatory requirement changes, either on individual product specification or quality systems.
- Understands and proactively follow through on the Environmental Management Procedures that have been identified as relevant to position.
Experience & Key Requirements
- Minimum qualification required: BSC/BEng degree. Significant relevant experience may be considered in lieu of a primary degree.
- Regulatory experience preferred but not essential
- Minimum 3 years’ experience in a Health Care environment in a technical function
- Experience in MDD, FDA, ISO, environment
- Strong team member with the ability to identify and drive regulatory compliance improvements
- Good administrative/organisational ability with excellent attention to detail
- Excellent communication skills
- Excellent analytical/decision making skills
For further information on this Regulatory Affairs Specialist II role in Cork please contact Clara Burke on 086 8168273 / email@example.com
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