Job Description

A Day in the Life

As the Regulatory Strategist for international regions you will focus on stakeholder engagement and partner closely with the Medtronic Diabetes Group Sr Staff, the Innovation organization and the Americas Commercial leader. You will build effective regulatory relationships with FDA.   Your responsibilities may include the following and other duties may be assigned.

Develops and leads strategies that provide a competitive advantage in the market in addition to the earliest possible approvals of new product development.
Establishes organization goals and objectives and leads regulatory personnel. Champions engagement, inclusion and diversity efforts as well as career development and performance management.
Partners with innovation leaders to support execution of regulatory strategy, provides guidance and ensures compliance with regulatory requirements
Develop and execute OEM (original equipment manufacturing) strategies. Partner with OEMs and build effective relationship to ensure safety and effectiveness of these entities’ products and services
Partners directly with health economics, reimbursement and government affairs to influences regulations globally in order to provide the best product position/price for our patients
Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
Leads or compiles all materials required in submissions, license renewal and annual registrations.
Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
Monitors and improves tracking / control systems.
Support new venture initiatives
Keeps abreast of regulatory procedures and changes.

Must Have: Minimum Requirements

Bachelors degree required
Minimum of 15 years of  relevant experience with 10+ years of managerial experience , or Advanced Degree with a minimum 13 years prior relevant experience with 10 years of managerial experience

Nice to Have

Medical device or highly regulated industry experience
Broad regulatory experience pre- and post- market
5+ years’ of 510K, PMA experience
SW experience including artificial intelligence, machine learning
Standard Council exposure/experience