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Regulatory Compliance Manager

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Waterford
  • Sector: Scientific
  • Date posted: 01/11/2017
  • Job reference: J376590A

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Regulatory Compliance Manager

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 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
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