Regulatory Affairs Specialist

Regulatory Affairs Specialist

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

Across our global Neuroscience organization, we advance care for some of medicine's most complex neurological and spinal conditions. By combining innovative technology, data-driven insights, and deep clinical expertise, we partner with physicians and health systems to improve how patients are treated and supported throughout their care journey.

Our Neuromodulation operating unit delivers advanced therapies for chronic pain, movement disorders, and nervous system conditions, offering SCS, DBS, and targeted drug delivery. Through proven technology, clinical evidence, and innovation, we provide personalized solutions that restore function and enhance quality of life.

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. We're working onsite 4 days a week at our Minnesota Rice Creek East facility to drive performance, foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary. In collaboration with leading clinicians, researchers, and scientists worldwide,

Role overview

The Regulatory Affairs Specialist develops strategies for worldwide product registration with Medtronic Geography Regulatory partners and global regulatory agencies to introduce products and changes to the market. This role involves:

• Providing expert advice on regulatory requirements
• Preparing submissions
• Supporting approval activities
• Assisting with license maintenance, including annual reports, renewals, design/manufacturing change notifications, QMS audits, and manufacturing site registrations

Responsibilities include, but are not limited to:

• Teaming with business unit Regulatory Affairs Specialists (RAS) and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products.
• Collaborating with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
• Preparing FDA, European, and Canadian submissions for product changes to ensure timely market release approvals.
• Reviewing regulatory issues with the manager as necessary and supporting the resolution of submission issues with engineering partners, geography regulatory partners, and regulatory agencies.
• Supporting regulatory compliance activities, including manufacturing site registration, audits, post-market vigilance reporting, and product recalls.
• Providing regulatory support for currently marketed products, including reviewing labeling and changes to existing devices and documentation.
• Providing feedback and ongoing support to product development teams for regulatory issues and questions.
• Interacting with FDA and international regulatory agencies on assigned projects/products, with significant issues reviewed with the manager.

To be successful in this role

• Medical Device Experience: Experience in the medical device industry, including exposure to Class II and/or Class III medical devices (510(k) and some PMA).
• Regulatory Submission Expertise: Experience preparing and supporting regulatory filings to the FDA (including 510(k) and some PMA), EU MDR, and other global regulatory agencies.
• Knowledge of Regulatory Requirements: Understanding of FDA requirements, guidance documents, EU MDR, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards.

Must have: minimum requirements

• Bachelor's degree in a scientific discipline or equivalent
• Minimum 2 years of regulatory affairs experience

Nice to have

• Experience in regulatory affairs, including conducting change assessments for Class II (510(k) devices).
• Advanced degree in a scientific discipline (engineering, physical/biological, or health sciences).
• Exposure to device submissions and interactions with 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.

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.

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Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.

Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.

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If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at View email address on click.appcast.io.

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): $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 applies solely to candidates hired within the United States (local-market compensation and benefits will apply to 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