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Details

Senior Regulatory Affairs Specialist


Reference:SGAQMI-557302 Location: Cork
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed

Senior Regulatory Affairs Specialist

Our client, a global medical device company are looking to hire a Senior Regulatory Affairs Specialist. This position will support NPD & product lifecycles while ensuring regulatory compliance is met throughout all regulatory processes.

Roles & Responsibilities

• Supporting new product development for both domestic and international release by contributing to the development and updating of regulatory strategy based upon regulatory changes.
• Supports the product lifecycle through to obsolescence by assessing changes made to the device post launch to determine regulatory impact of changes to the current clearance.
• Ensures regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies.

Skills & Qualifications

• B.Sc in Engineering, Sciences or equivalent preferred
• 1-3 years regulatory experience in the medical device or pharmaceutical industry
• RAC certification (preferred)
• Knowledge of the Quality System Regulations (21 CFR), Medical Device Directives (MDD) and MEDDEV guidance
• Knowledge of other regulations related to Pre Market Clearance and Post Market Support
• Ability to work with cross functional teams
• Ability to plan and conduct meetings
• Ability to negotiate internally and externally with FDA, NB and other regulatory bodies
• Excellent analytical and writing skills
• Effective organizational skills





If you would like further Information you can contact the recruiter directly:





Simon Gillivan | Tel: +353 (0) 1 507 9258





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