Principal Regulatory Affairs Specialist

Galway
​​Permanent
Overview:
  • Directs and influences the preparation of documentation to support high quality regulatory submission dossiers.
  • Partners with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies for changes to existing products.
  • Engages with regulatory agencies representing the company and ensuring the voice of the regulator is considered in developing regulatory strategies.
  • Engages with global international regulatory partners to support regulatory strategy for changes to existing products.
  • Leads regulatory filings to support submissions, license renewal and annual registrations. 
  • Support manufacturing strategy via a robust change control approach to ensure global approval and implementation of product and process changes.
  • Mentors and coaches’ other employees within the department and provides leadership support to ensure strong talent development.
  • Keeps abreast of regulatory procedures and changes. Supports industry advocacy activity to shape the future of evolving regulatory requirements. Develops internal procedures to ensure continuous compliance with all regulatory requirements.
  • Influences clinical evidence strategy to support labelling content, marketing claims and regulatory compliance. 
  • Supports regulatory compliance activities, including manufacturing site registration & GMP audits as needed.
  • Identifies and develops best practices within the Regulatory Affairs Department including continuous development initiatives.

Key Skills & Experience

  • We are looking for a qualified person to Level 8 Science or Engineering Degree/Masters. A Regulatory Affairs qualification is desirable, but not mandatory.  
  • Regulatory experience in Medical Devices and or Pharmaceuticals is required.
  • You are a recognized expert, capable of managing large projects or processes. 
  • You are a dynamic team player and can work effectively and pro-actively on activities both individually and in teams.
  • You have strong technical knowledge. You are skilled in thinking critically and making sound decisions.
  • You collaborate with others and create alignment with team members, at times acting as a team leader.
  • You are a strong coach/mentor and can provide coaching/training to other employees within the RA Department.
  • You set high standards and drive accountability in the execution of your responsibilities, and you model ethical behaviour.
  • You are a good communicator and fluent in English, both in writing and speaking with strong organizational skills.