Regulatory Compliance Manager
Hartley People
Waterford, Kilkenny, Tipperary
The Role. Provide support for the change management process. Provide international support for regional regulatory requests such as adding new products, registration renewal, registration support. Facilitate & support global Regulatory activities using a structured process and through engagement with our international regulatory professionals. Determine impact & identify appropriate implementation activities. Help solidify and strengthen the Global regulatory support network. Provide single point of contact for the regional informational requests for registration support and country specific requirements. Represent Regulatory Affairs on project/product development teams. Identifying the regulatory strategy for these activities. Responsible for the development of global regulatory strategies based on US FDA regulations, European Medical Device Directive, External Standards, and other international regulations. The Person. Minimum Bachelor’s Degree BS in engineering or scientific discipline (Chemistry, Biology, Microbiology or related technical field. 3-5 years’ experience in Regulatory Affairs essential. Strong knowledge of FDA & EU regulatory requirements essential. Other regional RA requirement knowledge an advantage. Hartley People Recruitment work to the highest ethical standards within our industry and we value the trust that you place in us when you send your CV. We can provide a full consultation in confidence and we guarantee that your CV will not be sent to any of our clients without your prior consent. For immediate consideration please call Sara on 051-878813 or email your CV in response to this job posting. Hartley People also recruit for similar roles such as Production Supervisor, Production Manager, Lean Manufacturing, Six Sigma, GMP, FDA, Production, Engineering, Manufacturing, Pharmaceutical, Medical, Devices. ISO 9000, Manufacturing Manager, Operations Manager, Assistant Operations Manager, Production Team Leader, Line Manager, Line Leader.
2327 days ago