Senior Medical Device Specialist

6 days ago


Limerick, Limerick, Ireland Cook Medical Full time

Company Overview:

Cook Medical is a leading manufacturer of medical devices, committed to improving patient outcomes through innovative products and services.

Our company values innovation, quality, and customer satisfaction, and we strive to maintain the highest standards in our operations and regulatory compliance.

We are seeking a highly skilled and experienced professional to join our regulatory affairs team as a Senior Regulatory Scientist.

Job Responsibilities:

  • Assist in the running of regulatory programmes and provide input into regulatory strategies
  • Implement regulatory requirements and ensure compliance with relevant ISO, EU, and FDA standards
  • Develop global regulatory strategies and plan and prepare regulatory submissions
  • Communicate status updates to stakeholders and collaborate with internal teams

Requirements:

  • Third-level qualification in science, engineering, or clinical field
  • 2+ years' experience in a regulated industry in a similar role
  • Knowledge of post-market surveillance and clinical evaluation regulations
  • Excellent communication and problem-solving skills
  • Ability to work in a team-based environment

What We Offer:

We offer a competitive salary and benefits package, including opportunities for professional growth and development. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply.



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