Associate Regulatory Affairs Specialist

Job Summary

Associate Regulatory Affairs Specialist (RAS) located in Lafayette, CO, as part of the Acute Care & Monitoring (ACM) group.

• Coordinate and prepare document packages for regulatory submissions, internal audits, and inspections.
• Lead or compile all materials required for submissions, license renewals, and annual registrations.
• Recommend changes for labeling, manufacturing, marketing, and clinical protocol to maintain regulatory compliance.
• Monitor and improve tracking and control systems.
• Stay current on regulatory procedures and changes.
• Direct interaction with regulatory agencies on defined matters.
• Recommend strategies for the earliest possible path to market.
• Support submissions and inquiries for global markets.
• Collaborate closely with R&D, clinical, operations, and marketing to embed regulatory requirements and strategy into product development and lifecycle management.
• Review promotional material for regulatory accuracy.

• Bachelor’s degree required.
• Minimum of 2 years of relevant experience, or an advanced degree with a minimum of 0 years of relevant experience.

• Experience in medical device regulation.
• Strong experience with Class I and II electrical and software‑based devices, including applicable standards.
• Strong knowledge of EU MDR, ISO 10993‑1, ISO 13485, and ISO 14971 risk‑management principles.
• Experience with regulatory requirements for cybersecurity, AI, and communicating devices (interoperability).
• Proven experience authoring and leading 510(k) submissions and EU Change Notifications.
• Strong experience compiling MDR Technical Documentation.
• Experience communicating directly with regulators.
• Collaborative, solution‑oriented performer focused on adding value to stakeholders and the organization.
• Proven ability to develop and execute robust regulatory strategies.
• Strong experience reviewing promotional materials for US/EU markets.

The role is primarily office‑based. Employees are regularly required to be independently mobile, work with a computer, and communicate with peers. Reasonable accommodations are available to enable individuals with disabilities to perform essential functions.

U.S. work‑authorization sponsorship (e.g., H‑1B, TN, J) 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.

Base salary range (U.S., excluding Puerto Rico): $74,400.00 – $. The position is eligible for a short‑term incentive called the Medtronic Incentive Plan (MIP).

Benefits include:

• Health, Dental, and Vision Insurance
• Health Savings Account
• Health 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 with employer contribution and match
• Short‑term Disability
• Paid Time Off and Paid Holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• Non‑qualified Retirement Plan Supplement
• Capital Accumulation Plan (for Vice Presidents and above, or subject to IRS earning minimums)

Additional details are available upon request.

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.