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Medical Device Regulation Specialist

3 weeks ago

Sligo, Sligo, Ireland beBeeRegulatory Full time €70,000 - €85,000
Global Medical Device Regulatory Documentation Specialist

As a Global Medical Device Regulatory Documentation Specialist, you will be responsible for ensuring compliance with regulatory requirements for medical devices. This involves generating documentation to support global medical device registration and ongoing compliance.

The role requires developing and implementing global standardized operating procedures and leading the development and maintenance of local medical device vigilance systems. You will work closely with cross-functional teams to establish the company as a medical device subject matter expert.

Key Responsibilities:

  • Organize and manage a highly compliant global medical device system.
  • Ensure compliance with established and updated local and global medical device processes, regulations, and guidelines.
  • Develop and implement training programs for personnel involved in medical device activities.
  • Monitor system performance, track compliance metrics, and report to leadership.

Requirements:

  • Master's degree in a related health science or equivalent experience.
  • RAC certification is a plus.
  • 5-7 years of experience in medical device regulatory submissions under EUMDR / MedDEV, with knowledge of standards like ISO, GSPR, and MDGC.
  • Strong understanding of medical device regulatory requirements and compliance processes.
  • Medical knowledge supporting safety activities; experience with nutrition/nutritional products is advantageous.
  • Knowledge of global Vigilance reporting regulations.

Benefits:

  • Opportunity to work in a dynamic and fast-paced environment.
  • Chance to develop skills and expertise in medical device regulation.
  • Collaborative team environment.

This is an exciting opportunity for someone who is passionate about medical device regulation and compliance. If you are looking for a challenging role that allows you to make a significant impact, apply today