Principal Regulatory Affairs Specialist

Posted 09 November 2020
SalaryNegotiable
Location
Job type Contract
DisciplineEngineering Leaders and Specialists, Life Sciences & Engineering Technologies
ReferenceBBBH28127_1604910105
ContactAnna Carey

Job description

Our client is one of the world's leading Medical Device companies. Due to continuous expansion, a new position for Principal Regulatory Affairs Officer has arisen at their Co. Galway facility.

The Position:

  • 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.

The Person:

  • 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.

Benefits:

  • 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.