Regulatory Affairs Specialist
Contract
Galway

Position Overview:

This role is responsible for planning, coordinating, and executing regulatory submissions for the US FDA, EU notified bodies, and global product registrations. It also involves maintaining ongoing compliance with regulatory approvals and performing change impact assessments.

Key Responsibilities:

• Support regulatory activities with a focus on Coronary Therapy devices as part of a collaborative team.

• Prepare and submit regulatory documentation for U.S. and EU markets, including PMAs, CE Marking submissions, and internal regulatory files.

• Serve as a regulatory representative on cross-functional product development teams, offering strategic guidance throughout the product lifecycle.

• Review and approve design and manufacturing changes to ensure compliance with relevant regulations.

• Support product registrations and approvals across international markets.

• Contribute to continuous improvement initiatives aligned with the organization's Quality Management System and applicable regulatory standards.

• Collaborate on enhancing team practices and promoting knowledge sharing and regulatory best practices.

• Participate in sustaining activities under product lifecycle management processes.

• Assist in preparing for and participating in regulatory inspections and audits (e.g., FDA, EU Notified Bodies, national authorities).

Qualifications & Experience:

• Degree (Level 8 or equivalent) in a Science or Engineering discipline.

• Strong interpersonal and teamwork skills.

• Excellent verbal and written communication, including technical writing ability.

• Proven ability to manage multiple priorities and projects effectively.

• Prior experience in Regulatory Affairs or Design Assurance is desirable.

• Familiarity with drug-device combination products or manufacturing processes in the medical device or pharmaceutical industry is an advantage.