Regulatory Affairs Specialist

Responsibilities

• Prepare, review, and file premarket documents for global registrations for assigned projects
• Develop regulatory strategies for new or modified products
• Collaborate with business units and international regulatory affairs personnel to support marketing authorizations
• Review pre-clinical and clinical protocols and associated reports for use in submissions
• Monitor and provide information regarding changes in the regulatory environment
• Document and maintain oral and written communication with health authorities
• Review change control documents to ascertain regulatory impact for internal and external documents
• Review promotional material, advertising, and labeling to ensure regulatory compliance
• Participate in health agency inspections and notified body audits as necessary

Requirements

• Bachelor's degree in medical, mechanical, electric, life science, or other healthcare-related majors
• 4-7 years of experience in a regulatory affairs role within the medical device or pharmaceutical industry
• Strong understanding of regulations and policies issued by India, US FDA, and EU
• Excellent written, organizational, and communication skills
• Ability to handle multiple tasks, work under pressure, and maintain strong attention to detail

Preferred Qualifications

• RAPS Regulatory Affairs Certification (RAC)
• Experience working with cross-functional teams and project management
• Extensive knowledge of US and global regulatory affairs
• Strong interpersonal and negotiation/influencing skills

Benefits

• Competitive salary and flexible benefits package
• Eligibility for the Medtronic Incentive Plan (MIP)
• Opportunities for long-term career growth and innovation

About the Company

Medtronic is a global leader in healthcare technology, 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 engineering and innovation.