Principal Regulatory Affairs Specialist

Mason Alexander; Burlington; Hybrid; CAD 85,000 - 115,000; Full time

Job summary

A leading medical technology firm in Burlington is seeking a Principal Regulatory Affairs Specialist to lead regulatory strategy and execution for pivotal device submissions. Candidates should have over 8 years of experience in regulatory affairs, preferably with Class III cardiovascular devices. This role offers a hybrid work model and the chance to impact patient care through innovative technology.

Benefits

Flexible hybrid work arrangement

Opportunity to impact patient care

Qualifications

• 8+ years of experience in Regulatory Affairs within medical devices.
• Experience preparing regulatory submissions like IDE, 510(k), PMA.
• Knowledge of Class III cardiovascular devices highly preferred.

Responsibilities

• Lead regulatory strategy and execution for EU and US submissions.
• Prepare and maintain regulatory documentation for medical devices.
• Monitor global regulations to ensure compliance.

Skills

Regulatory strategy and execution

Regulatory submissions for clinical trials

Knowledge of FDA regulations

Excellent communication skills

Cross-functional collaboration

Education

Bachelor’s degree in Engineering or Life Sciences

Job description

As Principal Regulatory Affairs Specialist, you will play a critical strategic and hands-on role in supporting global regulatory activities during a pivotal time. You will be the lead regulatory expert , working closely with the VP of Clinical and Regulatory (based in California) to ensure the successful regulatory planning of a novel device.

Key Responsibilities

• Lead regulatory strategy and execution for EU and US regulatory submissions, including clinical trial applications and IDE submissions.
• Collaborate cross-functionally with R&D, Quality, and Clinical teams to ensure regulatory requirements are integrated into design and development.
• Prepare and maintain regulatory documentation, including technical files, design dossiers, and clinical evaluation reports.
• Represent Regulatory Affairs in project teams and during design reviews.
• Monitor and interpret applicable global regulations, guidance documents, and standards to ensure compliance.
• Support interactions with regulatory agencies (e.g., HPRA, FDA) including responses to queries and pre-submission meetings.
• Provide regulatory input into risk management, labeling, IFUs, and product claims.

Required Qualifications & Experience

• Bachelor’s degree in Engineering, Life Sciences, or a related field (Master’s preferred).
• 8+ years of experience in Regulatory Affairs within the medical device industry, preferably in Class III cardiovascular devices.
• Demonstrated success in preparing regulatory submissions for clinical trials and/or market approval (IDE, 510(k), PMA).
• Strong knowledge of FDA regulations and guidance.
• Experience working in fast-paced development environment highly desirable.
• Excellent written and verbal communication skills.
• Ability to work effectively in a hybrid model and manage communication across time zones.

Why Join?

• Be part of an innovative company developing life-saving technology.
• Join at a transformative stage just prior to first-in-human studies.
• Collaborate with a high-caliber international team.
• Flexible hybrid work arrangement with a Galway-based HQ.
• Opportunity to shape regulatory strategy and have a direct impact on patient care.