About the Role
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.
A Day in the Life
Medtronic's Advanced Energy Operating Unit develops technologies that support surgical procedures that require vessel sealing and dissection. As part of Medtronic's broader mission, this team is focused on advancing innovative tools that help improve procedural outcomes and support high-quality patient care.
As a Regulatory Affairs Specialist in the Advanced Energy Operating Unit, you will play an important role in supporting innovative medical technologies throughout the product lifecycle. You will partner with cross-functional teams to prepare regulatory documentation, assess the impact of product changes, maintain regulatory systems, and help ensure compliance with global requirements.
This role is ideal for someone who thrives in a collaborative environment, enjoys navigating complex regulatory requirements, and is energized by the opportunity to support technologies that improve patient care.
Responsibilities
Responsibilities may include the following, as well as other duties that may be assigned:
•Partner with multidisciplinary teams to communicate regulatory requirements and support regulatory strategy.
•Provide regulatory input to product development, lifecycle planning, and change control activities.
•Assess the regulatory impact of proposed design, labeling, manufacturing, and process changes.
•Prepare, review, and coordinate documentation for regulatory submissions, renewals, registrations, and related filings.
•Support audits, inspections, and regulatory authority interactions as needed.
•Participate in risk management activities and help ensure regulatory considerations are addressed appropriately.
•Monitor and support tracking systems used to manage regulatory deliverables and documentation.
•Stay current on applicable regulations, standards, and guidance documents relevant to assigned products and markets.
•Collaborate with internal stakeholders to help resolve issues, manage priorities, and keep regulatory activities on track.
•Contribute to process improvements and help strengthen regulatory practices across the organization.
Must Have: Minimum Requirements
•Bachelor's degree required
•Minimum of 2 years of relevant experience, or advanced degree with a minimum of 0 years of relevant experience
Nice to Have
•Experience with U.S. FDA and international regulatory requirements for medical devices
•Familiarity with EU MDR, MDD, ISO 13485, ISO 14971, and related standards
•Experience supporting regulatory submissions, audits, or inspections
•Strong written and verbal communication skills
•Strong organizational skills with the ability to manage multiple priorities
•Experience collaborating in a cross-functional, fast-paced environment
•Familiarity with medical device product development or lifecycle management
•RAC certification or progress toward certification
•Experience working with Notified Bodies or global regulatory agencies
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.
U.S. Work Authorization & Sponsorship
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.
Salary ranges for U.S (excl. PR) locations (USD): $74,400.00 - $111,600.00
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
The base salary range is applicable across the United States, excluding Puerto Rico and specific 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.
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, and 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), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
The application window for this opening is anticipated to close on 12 Nov 2026.
