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
Supporting Design and Development Control activities with regulatory requirements, direction, tactics and strategies and working in a team workplace 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 recent or modified products for assigned projects.
Monitor and provide information pertaining to impact of changes in the regulatory workplace.
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 mat