Our client is one of the world's leading Medical Device companies. Due to continuous expansion, a new position for Principle Regulatory Affairs Officer has arisen at their Co. Galway facility.
- Directs and influences the preparation of documentation to support high quality regulatory submission dossiers.
- Engages with global international regulatory partners to support regulatory strategy for new products/therapies and changes to existing products. Partners with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies.
- Engages with global regulatory agencies representing the company and ensuring the voice of the regulator is considered in developing global regulatory strategies.
- Leads regulatory filings to support submissions, license renewal and annual registrations.
- Level 8 Bachelor's Degree/Masters or equivalent in Science, Engineering or related discipline.
- Regulatory experience in Medical Devices and or Pharmaceuticals is desirable, however, candidates with a minimum of 6 year's relevant experience will also be considered.
- Work from home
- Long term contract
- Attractive Pay Rate
To learn more about this role apply online or contact Anna Carey on +353 873928655 or for a confidential discussion.