Regulatory Affairs Specialist

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 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.