Medical Devices JobsSenior Regulatory Affairs Specialist

  • GY51657
  • Temporary/Contract
  • Galway

Collins McNicholas

A global Medical Device organisation in Galway is seeking an experienced Regulatory Affairs professional to join their business on a 12-month contract

Key Duties

  • Directs or performs coordination and preparation of document packages for regulatory submissions.
  • Teams with business unit Regulatory Affairs Specialists and international regulatory staffs to provide regulatory support for new products/therapies and changes to existing products. Work with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies.
  • Leads or compiles all materials required in submissions, license renewal and annual registrations.
  • Recommends changes for labeling, manufacturing, marketing, and clinical protocol/evaluation reports for regulatory compliance.
  • Keeps abreast of regulatory procedures and changes. Develop internal procedures to ensure continuous compliance with all regulatory requirements.
  • May direct interaction with regulatory agencies on defined matters.
  • Support regulatory compliance activities, including manufacturing site registration & GMP audits as needed.
  • Identify and develop best practices within the Regulatory Affairs department including continuous development initiatives (MOS/COS)

What is required?

  • Bachelors degree required
  • Minimum of 4 years of relevant experience or advanced degree with a minimum of 2 years relevant experience in Medical device or Pharma is essential
  • Experience or working with regulatory files for USA / EU
  • Lead projects/programs on own initiative and filed them
  • Experience working directly with the FDA, and notified bodies in Europe
  • Experience working with Class III medical devices or DMS Drug master file
  • Experience filing using the ECTS system

Please get in touch for a confidential discussion on;

091 706 718

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