Regulatory Affairs Specialist at Medtronic in Memphis, Tennessee

Job Description:

Careers that Change Lives

Our Diversity Networks and Employee Resource Groups (ERGs) are building a sense of community, belonging, and activation for Medtronic employees. Medtronic supports diversity networks and ERGs focused on various areas such as gender, ethnicity, age, faith, sexual orientation, military veteran status, disability status, and other shared affinities.

Part of the Neuroscience portfolio, Cranial and Spinal Technologies (CST) is redefining cranial and spinal procedures to reduce variability and improve outcomes to restore long-term quality of life for more patients. CST comprises four global businesses: Spine & Biologics, Enabling Technologies, intelligent Data Solutions (iDS), and China Cranial, Spinal, Orthopedics & Technologies.

• Spine & Biologics offers procedural solutions for spine surgery and bone grafting solutions for spinal fusion.

• Enabling Technologies delivers an innovative portfolio that includes robotics, navigation, intra-operative imaging, advanced energy devices, cerebral spinal fluid management, and critical care.

• Intelligent Data Solutions (iDS) , with Medicrea as the foundation, is revolutionizing the standard of care for personalized spine surgery using data science and Artificial Intelligence (AI) so all spine surgeons can provide predictable and reproducible patient outcomes.

• China Cranial, Spinal, Orthopedics & Technologies provides solutions in spine surgery, neurosurgery, surgical synergies, biologics, and orthopedics.

A Day in the Life

Responsibilities may include the following and other duties may be assigned.

• Directs or performs coordination and preparation of document packages for regulatory submissions from all company areas, internal audits, and inspections.
• Leads or compiles all materials required for submissions, license renewals, and annual registrations.
• Acts as regulatory lead on project teams providing strategies and guidance.
• Recommends labeling, manufacturing, marketing, and clinical protocol changes for regulatory compliance.
• Monitors and improves tracking/control systems.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.

Must Have: Minimum Requirements

• Bachelor's degree required
• Minimum of 2 years of relevant experience

• Direct experience with FDA and EU MDR submissions.
• Experience providing regulatory input to project teams.
• Demonstrated ability to work effectively with local and global team members.
• Experience evaluating changes to medical devices for regulatory compliance.

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 an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform 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.

A commitment to our employees' lives is at the core of our values. We recognize their contributions. They share in the success they help to create. We offer many benefits, resources, and competitive compensation plans to support you at every career and life stage. Learn more about our benefits here .

This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here .

The provided base salary range is used nationally in the United States (except in Puerto Rico and specific CA locations). The rate offered complies with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.