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Employer Brightwater
Job Title Regulatory Compliance Manager

A leading client in Waterford has an opening for an experienced Regulatory Compliance Professional to manage their compliance activities.

Purpose of the Role:

  • Quality oversight of Change Management
  • Regulatory support for regional RA
  • Strategic direction for regulatory requirements FDA & ISO 13485 including MDR introduction
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 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
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 business
  • Facilitate & support global Regulatory activities using a structured process and through engagement with our international regulatory professionals
For more on the role call Nigel on 021 4221000 or send your CV for consideration.

This job originally appeared on
Location Waterford
Date Added 68 days ago
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