Strategic Regulatory Compliance Expert

3 days ago

Galway, Galway, Ireland beBeeRegulatory Full time €93,440 - €107,460

Job Title: Regulatory Affairs Specialist

Job Summary

We are seeking a highly skilled and experienced Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for coordinating and preparing document packages for regulatory submissions, working with engineers and technical experts to develop robust regulatory strategies, and providing regulatory support for changes to existing products.

Key Responsibilities
  • Directs or performs coordination and preparation of document packages for regulatory submissions
  • Teams with other Regulatory Affairs Specialists and international regulatory specialists to provide regulatory support for 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
Required Skills and Qualifications

To be successful in this role, you will need:

  • A Level 8 Science or Engineering honours bachelor's degree
  • A minimum of 2 years of relevant experience in Medical Devices and/or Pharmaceuticals
  • Strong technical knowledge and analytical skills
  • Ability to work independently and under general direction only
  • Strong proficiency skills with I.T systems and data collection
Benefits

We offer a competitive salary and flexible benefits package, including:

  • Short-term incentive called the Medtronic Incentive Plan (MIP)
  • Opportunities for career growth and professional development
  • A dynamic and supportive work environment
About Us

We are a leading global healthcare technology company that is passionate about making a difference in people's lives. We value innovation, collaboration, and customer focus, and we are committed to delivering high-quality products and services that meet the needs of our customers.

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