Senior Regulatory Affairs Specialist

Employment Type
Not disclosed
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Role: Senior Regulatory Affairs Specialist

Client: Our client is a multinational medical device company that works to improve the world of health by improving the delivery of care, diagnostic and medical discoveries. The successful candidate will ensure the regulatory requirements for products such as programmable electrical medical devices, stand-alone software as medical devices, accessories and disposable infusion sets are met.

Location: Limerick

Core Responsibilities:

  • Aide in the development of regulatory strategies.
  • Maintain Regulatory procedures to ensure continued compliance.
  • Review and approve project documentation.
  • Ensure that updates to the Technical Files and international registrations are conducted appropriately.
  • Identify barriers, defining problems based on data/facts and seeking solutions.
  • Mentor and develop team members and support continuous improvement activities.

Experience Required:

  • Third level qualification in Electronics, Biomedical Engineering or related discipline.
  • 2+ years’ experience in a similar position.
  • Experience with regulatory submissions with exposure to mechanical and active devices and mobile applications.
  • Knowledge on EU MDR / UK MDR / EU MDD / MDSAP and ISO standards.