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Senior Reg Affairs Specialist

4 weeks ago

Galway, Galway, Ireland PE Global Full time

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PE Global is currently recruiting for a Senior Reg Affairs Specialist on behalf of a leading medical device company based in Galway. This is an initial 12-month contract role.

Responsibilities:

  • Directs or performs coordination and preparation of document packages for regulatory submissions.
  • Supports change control activities to support global approval and implementation of product and process changes
  • Leads or compiles all materials required in submissions, license renewal and annual registrations
  • Teams with business unit Regulatory Affair Specialists and international regulatory staff to provide regulatory support. Works with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies.
  • Recommends changes for labelling and internal documentation, reports for regulatory compliance
  • Keeps abreast of regulatory procedures and changes. Supports review of internal procedures to ensure continuous compliance with all regulatory requirements.
  • May have direct interaction with regulatory agencies on defined matters
  • Supports regulatory compliance activities, including manufacturing site registration & GMP audits as needed
  • Identifies and develops best practices within the Regulatory Affairs Department including continuous development initiatives

Education & Experience:

  • Level 8 Honor's Degree Science or Engineering bachelor's degree/master's with a minimum of 5 years of relevant experience, preferably with Class III devices. A Regulatory Affairs qualification is desirable, but not mandatory
  • Regulatory experience in Medical Devices, Pharmaceuticals, Software in a medical device or similar regulated industry is required
  • You are a dynamic team player and can work effectively and pro-actively on activities both individually and in teams
  • You have strong technical knowledge. You are skilled in thinking critically and making sound decisions. Ability to comprehend principles of engineering, physiology, and medical device use.
  • You collaborate with global cross functional teams and create alignment with team members.
  • Experience with FDA regulatory requirements, European Medical Devices Regulation (EU MDR), Regulation (EU) 2017/745 and international regulatory agency requirements
  • May provide guidance, coaching and training to other employees within job area.
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