Sr. Director Regulatory Affairs

Posted 14 November 2022
Salary Negotiable
Job type Permanent
DisciplineLife Sciences
Contact NameSophia Ondi

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

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)