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Details

Senior Regulatory Affairs Specialist


Reference:SMC10779 Location: Galway
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Regulatory Affairs

We’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Galway. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

• Guides conformance with applicable regulations in product development, support of claims, content labelling, and promotional materials. The role assists in the development of best practices for Regulatory Affairs processes.
• Helps define data and information needed for regulatory approvals in conjunction with cross-functional product development teams.
• Leverages a deep scientific and technical understanding of regulated products under scope of
responsibility to provide strategic guidance and support for product development and life-cycle
management of products (e.g. represents Regulatory in the complaint handling and field action process).
• Clearly defines and prioritises decision criteria, considers the benefits and risks of each solution before making decisions. Considers all of the available facts when situations are ambiguous in order to make the best possible decision.
• Develops labelling specifications and approves proposed labelling and packaging, after evaluating conformance to regulations is required.
• Represents Regulatory Affairs on cross-functional project teams.

Education & Experience

• Experience in regulatory affairs within the medical device industry
• Experience of inspection by an external agency, such as the FDA.
• Knowledge/working experience of the European Medical Device Directive/Regulation


If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or sean.mccarthy@lifescience.ie for further information.