Global Regulatory Affairs Specialist
Brightwater
Waterford
Are you a Senior Regulatory Affairs professional who is looking to make the step into a more strategic role? A key client of mine in the South East has a role that might both interest and challenge you. This has both local and Global responsibility so you`ll have exposure across their international sites. You`ll need to bring a strong background in Regulatory Affairs in a Medical Device company and at least 5 years of experience as you`ll be tasked with providing the strategic direction for the Regulatory Affairs function. This role doesn`t have any direct reports so you will be an individual contributor. Key Responsibilities: • Provide international support for regional regulatory requests such as adding new products, registration renewal, registration support. • Facilitate & support global Regulatory activities through engagement with our international regulatory professionals. The role will include the following activities with respect to implementation of new standards & regulations. • Determine impact & identify appropriate implementation activities required to implement new regulations & standards. • Help solidify and strengthen the Global regulatory support network and process through proactive engagement. • 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. • Responsible for the development of global regulatory strategies based on US FDA regulations, European Medical Device Directive, External Standards, and other international regulations. Qualifications and Requirements: • Minimum Bachelor’s Degree BS in engineering or scientific discipline (Chemistry, Biology, Microbiology or related technical field. • 5 years’ experience in Regulatory Affairs is necessary. • Knowledge of FDA & EU regulatory requirements necessary. • Other regional RA requirement knowledge an advantage. Interested? Call Nigel on 021 4221000 or send your CV for consideration. This job originally appeared on RecruitIreland.com.
2297 days ago