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.
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.