Regulatory Compliance Manager
ICDS Recruitment
Waterford
Regulatory Compliance Manager. Waterford. Purpose of the Role: Quality oversight of Change Management. Regulatory support for regional RA to support the business. Strategic direction for contact lens regulatory requirements FDA & ISO 13485 including MDR introduction. Key Responsibilities : Provide support for the change management process including governance and QPI metric reporting. Provide international support for regional regulatory requests such as adding new products, registration renewal, registration support. Provide strategic direction to support the growing global contact lens business. Facilitate & support global Regulatory activities using a structured process and through engagement with our international regulatory professionals. Scope of the Role: 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 in relation to contact lens operations globally. Help solidify and strengthen the Global regulatory support network and process through proactive engagement with international peers and key stakeholders. 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 and identifying the regulatory strategy for these activities. Responsible for the development of global regulatory strategies for contact lenses 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. 3-5 years’ experience in Regulatory Affairs is necessary. Knowledge of FDA & EU regulatory requirements necessary. Other regional RA requirement knowledge an advantage. This job originally appeared on RecruitIreland.com.
2234 days ago