We anticipate the application window for this opening will close on - 25 Jul 2025

 

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

SENIOR REGULATORY AFFAIRS SPECIALIST

In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.

Saving lives for us is not just a cliché but is part of our everyday DNA.   Real people with debilitating conditions can now be given back active lives through the restorative therapies that we provide.  Therefore, we are looking for passionate engineers who are excited about working in the software field and testing revolutionary mobile and web-based applications that directly affect and improve patient’s lives. 

The Senior Regulatory Affairs Specialist develops strategies for worldwide product registration with Medtronic Geography Regulatory partners, and global regulatory agencies to introduce products and changes to market, provides advice on regulatory requirements, prepares submissions and negotiates their approval.  The Senior RA Specialist also assists with the license maintenance including annual reports, renewals, design/manufacturing change notification, QMS audit, and Manufacturing site registrations.

Neuroscience Portfolio

The Neuroscience Portfolio group develops life-restoring therapies and healthcare solutions that span the neurological care continuum including integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.  The software that we produce supports the following areas:

Spinal Cord Stimulation: https://www.medtronic.com/us-en/healthcare-professionals/products/neurological/spinal-cord-stimulation-systems.html

Deep Brain Stimulation: https://www.medtronic.com/us-en/healthcare-professionals/therapies-procedures/neurological/deep-brain-stimulation.html

Sacral Neuromodulation : https://www.medtronic.com/us-en/healthcare-professionals/therapies-procedures/urology/sacral-neuromodulation.html

Targeted Drug Delivery: https://www.medtronic.com/us-en/healthcare-professionals/therapies-procedures/neurological/targeted-drug-delivery.html

Career growth and development is about learning and stretching yourself to grow your expertise and navigate your career. Medtronic offers award-winning programs to accelerate your development and growth. Our size, scope and market leadership give you the chance to explore career opportunities  and grow as we grow. 
 

A Day In The Life

• Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products. Work with RAS, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
• Collaborate with marketing and medical education groups on claims for new promotional materials.
• Review and approve advertising, promotional and educational materials for compliance with regulatory requirements.
• Apply regulatory and therapeutic area knowledge to marketing objectives and initiatives to develop solutions to complex US promotional issues.
• Interact directly with FDA and/or indirectly with international regulatory agencies on most projects/products at reviewer level. All significant issues will be reviewed with the manager.
• Support regulatory compliance activities, including manufacturing site registration, audits, post-market vigilance reporting, product recalls, etc., as needed.
• Provide business and pr