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Regulatory Affairs Specialist

Regulatory Affairs Specialist

Regulatory Affairs Specialist - Galway - Medical Devices

 

This Regulatory Affairs Specialist is responsible for coordinating, preparing, and maintaining regulatory submissions on a global level including European CE-marking and US FDA submissions.

Stand alone opportunity in a growing Medical Devices offering excellent opportunity for growth.

Primary responsibilities are to ensure regulatory compliance for assigned product lines.

 

Responsibilities

  • Evaluates potential global regulatory pathways for various projects for EU, US and International product launches / product enhancements.
  • Prepares regulatory submissions to regulatory authorities and/or distributors (including the FDA, Notified Bodies, Health Canada and other regulatory authorities).
  • Maintains expertise in worldwide regulatory requirements, with an emphasis on MDR; establishes and maintains positive relationships with regulators.
  • Interacts directly with international regulatory agencies on products / projects at reviewer level. Interacts with various levels of management, external agencies and companies. Works with engineers and technical experts to resolve potential regulatory issues and questions from Regulatory Agencies.
  • Provides support for commercialized products as necessary by reviewing labelling, promotional materials, and product and documentation changes per policy and procedure.
  • Maintains and enhances cross-functional team relationships. Provides technical guidance and regulatory training / mentoring to other Regulatory Affairs employees and cross-functional teams.
  • Participates in and assists with Notified Body Audits, MDSAP, FDA facility inspections, and other governmental inspections, as directed.

 

Qualifications

  • An Engineering or Quality Assurance Degree or equivalent experience.
  • A minimum of eight (8) years within a Medical Device or regulated environment with at least five (5) of those years working as a Regulatory Specialist.
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