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
setting 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 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