Regulatory Affairs Specialist

Responsibilities

• Develop worldwide product registration strategies for cardiac arrhythmia and heart failure products.
• Provide regulatory advice and support to project teams regarding global requirements and guidance.
• Prepare and manage worldwide regulatory submissions and negotiate approvals with global agencies.
• Assist with license maintenance, including renewals, design/manufacturing change notifications, and manufacturing site registrations.
• Review labeling and documentation for currently marketed products to ensure ongoing compliance.
• Maintain Regulatory Affairs product files and perform regulatory analysis of the product portfolio.
• Stay current on global directives and harmonized standards, communicating changes to cross-functional teams.

Requirements

• Bachelor's degree in a technical discipline.
• Minimum 2 years of medical device regulatory experience (or 0 years if you possess an advanced degree).
• Knowledge of FDA requirements and global regulatory standards.
• Understanding of ISO 14971 and ISO 13485.
• Proficiency with MS Office and Agile.

Preferred Qualifications

• Experience in a regulated biotechnology environment with direct interaction with agencies like the FDA or PMDA.
• Master of Science degree.
• Strong negotiation, organizational, and time management skills.
• Ability to multitask and manage multiple projects on a global basis.

Benefits

• Competitive salary and Medtronic Incentive Plan (MIP).
• Comprehensive health, dental, and vision insurance.
• Health Savings Account (HSA) and Flexible Spending Account (FSA) options.
• 401(k) plan with employer contribution and match.
• Paid time off and paid holidays.
• Tuition assistance and reimbursement programs.
• Employee Stock Purchase Plan.

About the Company

Medtronic is a global leader in medical technology, dedicated to alleviating pain, restoring health, and extending life. Our Cardiac Rhythm Management division focuses on developing innovative solutions for cardiac arrhythmias and heart failure, including pacemakers and ICDs, to improve patient outcomes worldwide.