Calling all RA Specialists – we are currently recruiting for a Principal RA Specialist to join a pioneering organization at the forefront of developing innovative strategies for regulatory approval in the Galway-based Regulatory Affairs department.
Responsibilities include
• Oversee the creation of high-quality regulatory submission dossiers.
• Collaborate with engineers and technical experts to formulate robust regulatory strategies and address inquiries from regulatory agencies regarding product modifications.
• Act as a representative of the company in engagements with regulatory agencies, ensuring their input is integrated into regulatory strategies.
• Partner with international regulatory counterparts to guide strategy for modifications to existing products.
• Lead regulatory filings for submission, license renewal, and annual registrations.
• Drive manufacturing strategy through a comprehensive change control approach to secure global approval and implementation of product and process changes.
• Provide mentorship and coaching to departmental colleagues, offering leadership support for robust talent development.
• Stay updated on evolving regulatory procedures and changes. Advocate for industry initiatives to shape future regulatory requirements. Develop internal procedures to ensure ongoing compliance with all regulatory standards.
• Influence the strategy for clinical evidence to support labelling content, marketing claims, and regulatory compliance.
• Support regulatory compliance efforts, including site registration and GMP audits as required.
• Identify and foster best practices within the Regulatory Affairs Department, including continuous development initiatives.
Key Skills & Experience:
• A Level 8 Science or Engineering Degree/Masters is required. A Regulatory Affairs qualification is beneficial but not mandatory.
• Prior regulatory experience in Medical Devices and/or Pharmaceuticals is essential.
• You are a recognized expert capable of overseeing significant projects or processes.
• A dynamic team player, adept at both independent and collaborative work.
• Possess strong technical acumen with critical thinking and decision-making skills.
• Collaborative mindset with the ability to align with team members, occasionally taking on a leadership role.
• Proficient in coaching and mentoring, providing guidance and training within the RA Department.
• Set and uphold high standards, instilling accountability in your responsibilities while exemplifying ethical conduct.
• Strong communication skills in English, both written and verbal, with excellent organizational abilities.