Regulatory Affairs Specialist

Regulatory Affairs Specialist

Medtronic's Access and Instruments Operating Unit develops technologies that support surgical access and enable precise, efficient procedures across a range of care settings. The portfolio includes products and solutions designed to help clinicians access the surgical site, perform procedures with greater control, and support workflow in the operating room. 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 Access and Instruments 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.

In this role, you will:

• 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.

To be considered for this role, you must have:

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

Preferred qualifications include:

• 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

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): $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. Compensation and benefits information pertains 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, 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).

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.