Associate Regulatory Affairs Specialist - Onsite

We anticipate the application window for this opening will close on - 7 Nov 2026

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

The Cranial and Spinal Technologies (CST) Operating Unit develops and delivers technologies for treating spinal and cranial conditions. The organization partners with healthcare professionals worldwide to support procedural planning, navigation, biologics, implants, and enabling technologies designed to improve patient outcomes.

The Regulatory Affairs function supports product compliance and regulatory strategy throughout the product lifecycle by coordinating submissions, registrations, renewals, and regulatory documentation. This team collaborates with cross-functional stakeholders to help ensure products, processes, and labeling activities meet applicable regulatory requirements while supporting business objectives within the CST portfolio.

This position is based in Memphis, Tennessee, and is an on-site role. No travel is required.

Job Description field

The Associate Regulatory Affairs Specialist supports regulatory activities for the Cranial and Spinal Technologies portfolio by coordinating documentation, preparing submission materials, maintaining regulatory records, and assisting with compliance initiatives. This role partners with cross-functional teams to help ensure timely and accurate regulatory submissions while supporting regulatory inspections, audits, and ongoing business operations.

Primary Responsibilities

• Coordinate the preparation, assembly, and maintenance of regulatory submission packages and supporting documentation.
• Compile materials required for regulatory submissions, license renewals, annual registrations, and related filings.
• Support internal and external audits, inspections, and regulatory inquiries by gathering and organizing requested documentation.
• Review regulatory documentation and recommend updates to labeling, manufacturing processes, marketing materials, and clinical protocols to support compliance requirements.
• Maintain and improve systems used to track regulatory submissions, commitments, approvals, and records.
• Monitor regulatory requirements, guidance updates, and procedural changes to support ongoing compliance activities.
• Collaborate with cross-functional teams to ensure regulatory deliverables are completed accurately and according to established timelines.
• Support regulatory strategies and activities associated with obtaining and maintaining product approvals and registrations.

Required Qualifications

• Bachelor's degree

Preferred Qualifications

• Experience supporting regulatory submissions, registrations, renewals, or regulatory compliance activities.
• 1+ year of experience in Regulatory Affairs, Quality, Clinical, Medical Device, Life Sciences, Healthcare, or another regulated environment.
• Knowledge of United States and/or international regulatory requirements and regulatory documentation practices.
• Experience using Microsoft Office applications, including Word, Excel, Outlook, and PowerPoint.
• Experience using regulatory information management, document control, or quality management systems.

For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

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.

U.S. Work Authorization & Sponsorship

At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. …