Regulatory Affairs Specialist

Responsibilities

• Lead or compile all materials required for regulatory submissions, license renewals, and annual registrations.
• Work closely with engineers and technical experts to address inquiries from regulatory agencies.
• Provide support for marketed products, including reviewing labeling, product changes, and process changes.
• Prepare submissions and reports for the FDA and provide documentation for international submissions.
• Maintain proficiency in worldwide regulatory requirements and assess device changes for regulatory implications.
• Establish and maintain positive relationships with cross-functional teams and regulatory agency reviewers.

Requirements

• NFQ Level 8 Bachelor’s degree in Regulatory Science, Pharmaceutical, Biomedical, or a related scientific field with at least 2 years of relevant medical device industry experience.
• Alternatively, a Master’s degree in a related field with no prior industry experience.
• Knowledge of Class II and Class III medical devices.
• Understanding of FDA, MDD, and MDR requirements.

Preferred Qualifications

• Experience working specifically with Class II/III medical devices.
• Familiarity with FDA guidance documents and global quality standards.
• Strong negotiation, written, and oral communication skills.
• Excellent organizational, time management, and interpersonal skills.

Benefits

• Competitive salary ranging from EUR 48,400 to EUR 72,600.
• Eligibility for the Medtronic Incentive Plan (MIP).
• Flexible benefits package designed to support various career and life stages.

About the Company

Medtronic is a global healthcare technology leader dedicated to alleviating pain, restoring health, and extending life. Our mission unites a global team of over 95,000 passionate people working to solve the most challenging health problems facing humanity through innovation and engineering excellence.