Associate Regulatory Affairs Specialist - On-site

About the role

Medtronic is a global leader in healthcare technology with a mission to alleviate pain, restore health, and extend life. The Cranial and Spinal Technologies (CST) Operating Unit develops and delivers technologies for treating spinal and cranial conditions, partnering 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, collaborating with cross-functional stakeholders to 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 with no travel required.

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
• 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.

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.

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, interact with a computer, and communicate with peers and co-workers.

U.S. Work Authorization & Sponsorship

U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Pay

Salary range for U.S. (excluding Puerto Rico) locations: $60,800.00 – $91,200.00 USD. This position is eligible for the Medtronic Incentive Plan (MIP). The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location.

Benefits

• Health, dental, and vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long-term disability leave
• Dependent daycare spending account
• Tuition assistance/reimbursement
• Simple Steps (global well-being program)
• Incentive plans
• 401(k) plan plus employer contribution and match
• Short-term disability
• Paid time off
• Paid holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Some benefits may not apply to workers in Puerto Rico.