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View Cache (Job ID 13850392)
Employer Brightwater
Job Title Global Regulatory Affairs Specialist

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
Location Waterford
Date Added 8 days ago
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