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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 69 days ago
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