Regulatory Affairs Specialist

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About the role

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Responsibilities may include the following and other duties may be assigned: • Prepare, review, file, and support premarket documents for global registrations for assigned projects. • Collaborate with business unit and international regulatory affairs personnel to support marketing authorizations for assigned projects. • Review pre-clinical, and clinical protocols and associated reports to be used in submissions for assigned projects. • Develop Regulatory Strategies for new or modified products for assigned projects. • Monitor and provide information pertaining to impact of changes in the regulatory environment. • Document, consolidate, and maintain oral and written communication with health authorities • Prepare internal documents for modifications to devices, when appropriate. • Compiles all materials required in submissions, license renewal and annual registrations • Participate in health agency inspections & notified body audits as necessary. • Author and/or review regulatory procedures and update as necessary. • Review change control documents and ascertain regulatory impact for external and internal documents through formal regulatory assessments. • Assist in development/maintenance of regulatory files, records, and reporting systems of systematic retrieval of information. • Review promotional material, advertising, and labeling to ensure regulatory compliance on assigned projects. • Ensure compliance to regulations specific to clearance and approvals of OU developed product’s raw material and/or prototype. Required knowledge and experience: • Bachelor’s degree in medical, Mechanical, Electric Life Science or other healthcare related majors • 4-7 year’s experience for RA role in medical device and or pharmaceutical industry. A mix is preferred in case of pharma • Good understanding for regulations and policies issued by India, US FDA and EU, and ability to interpret international regulatory requirements. • Excellent written, organizational, and communication skills is required, and have a flexible and team-oriented attitude. • Strong attention to details and ability to handle multiple tasks, good at planning and can work under pressure, Good at English including reading, writing, and speaking. • Good Learning attitude. Nice to Have • US and global regulatory affairs knowledge and experience. • Experience working with cross-functional teams. • Effective verbal and written communication skills both internally and externally. • Experience with solving problems and concerns. • Experience with project management and adherence to time schedules. • Work well under pressure in a dynamic environment. • Highly organized, detail-oriented, and efficient. • Team player who seeks to help and learn from colleagues seeing the department success as their own • Ability to manage projects to completion within and outside of the direct department and company. • Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism • Proactively seeks to develop and become well-versed within the regulatory landscape. • RAPS Regulatory Affairs Certification (RAC).   Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employee

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