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Senior Regulatory Affairs Specialist | Galway | Hybrid

We are currently partnering with a leading, global, medical device client who are looking to hire a Senior Regulatory Affairs Specialist to join their growing team. This is a permanent position and will offer hybrid working. The Senior Regulatory Affairs Specialist plays a vital role within the team and will hold many responsibilities, ranging from technical to people development.


Responsibilities:

  • Directs or performs coordination and preparation of document packages for regulatory submissions.
  • Teams with business unit Regulatory Affair Specialists and international regulatory staff 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.
  • Supports change control activities to support global approval and implementation of product and process changes
  • Recommends changes for labelling, 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.
  • Identifies and develops best practices within the Regulatory Affairs Department including continuous development initiatives.

Key Skills & Experience

  • Qualified to Level 8 Science or Engineering Bachelor’s Degree/Masters with a minimum of 4 years of relevant experience. A Regulatory Affairs qualification is desirable, but not mandatory.  
  • Regulatory experience in Medical Devices and or Pharmaceuticals 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.
  • You collaborate with others and create alignment with team members.
  • May provide guidance, coaching and training to other employees within job area
  • You set high standards and drive accountability in the execution of your responsibilities and you model ethical behaviour.
  • You are a good communicator and fluent in English, both in writing and speaking with strong organizational skills.


For a confidential discussion on this role contact Amy Newell.

amy.newell@collinsmcnicholas.ie

091-706718