Associate Regulatory Affairs Specialist - On-site

Denttach LLC; Memphis, Northern (TN, KY); Hybrid; USD 61,000 - 91,000; Full time

Job summary

Medtronic in Memphis, TN is looking for an Associate Regulatory Affairs Specialist to coordinate regulatory submissions and maintain records for the Cranial and Spinal Technologies portfolio. The role supports inspections, audits, and compliance initiatives across the product lifecycle with cross-functional teams.

The candidate should have a bachelor’s degree and experience with regulatory documentation, US and international requirements, and MS Office tools.

Qualifications

• Bachelor's degree required.
• Experience supporting regulatory submissions, registrations, renewals, or regulatory compliance activities.
• Knowledge of US and international regulatory requirements and regulatory documentation practices.

Responsibilities

• Coordinate preparation and maintenance of regulatory submission packages.
• Support license renewals, annual registrations, and related filings.
• Gather documentation for audits, inspections, and inquiries.
• Review labeling, manufacturing processes, and marketing materials for compliance.
• Track regulatory submissions, commitments, and approvals.
• Collaborate with cross-functional teams to meet timelines.
• Support strategies for obtaining and maintaining product approvals and registrations.

Skills

Regulatory Affairs

Documentation

Cross-functional collaboration

MS Office

Education

Bachelor's degree

Tools

Regulatory information management

Document control systems

Quality management systems

Job description

We anticipate the application window for this opening will close on - 12 Sep 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. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. 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.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S (excl. PR) locations (USD):$60,800.00 - $91,200.00This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).The base salary range applies across the United States, excluding Puerto Rico and certain locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertaining solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week:

• 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)

The following benefits and additional compensation are available to all regular employees:

• 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. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

Medtronic benefits and compensation plans

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.