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 creative 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 environment with all organizational departments. Preparation of document packages for international regulatory submissions from all areas of company, internal audits and inspections
Responsibilities may include the following and other duties may be assigned:
Set up new process for entering new data - Regulatory Information Management System.
Process SME to ensure appropriate coordination and advise on consistent interpretation of required data attributes.
Keeps abreast of regulatory procedures and changes.
Provide requested regulatory data and documents to support tenders
Keeps abreast of regulatory procedures and changes.
Lead in development/maintenance of regulatory files, data, records, and reporting systems of systematic retrieval of information.
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.
Preparation of document packages for international regulatory submissions from all areas of company, internal audits and inspections.
Compiles all materials required in submissions, license renewal and annual registrations.
Recommends changes for labelling, manufacturing, marketing and clinical protocol for regulatory compliance.
Monitors and improves tracking/control