Regulatory Affairs Specialist

Medtronic — Nanakramguda, Hyderabad, India

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Supporting Design and Development Control activities with regulatory requirements, direction, tactics and strategies and working in a team environment with all organizational departments. 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: Bac

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