We anticipate the application window for this opening will close on - 29 May 2026

At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.

A Day in the Life

At Medtronic we are driven by our Mission to alleviate pain restore health and extend life for patients around the world. As part of the Robotics Surgical Technology business you will help support innovative robotic-assisted surgical solutions that combine hardware software and clinical application to expand access to minimally invasive care. This role offers the opportunity to work in a highly collaborative global environment where regulatory strategy directly supports product innovation continued compliance and patient access across international markets.
The Sr. Regulatory Affairs Specialist will play a key role in planning developing and executing global regulatory strategies and submissions necessary to obtain and maintain regulatory approvals in international markets for Class II robotic medical devices. This role will partner closely with Geography Regulatory Affairs to support international submissions government queries registration documentation product approval and clearance activities product demand and release planning and post-market regulatory compliance to help ensure continued product availability worldwide. The Sr. Regulatory Affairs Specialist will also represent the OUS regulatory function in sustaining and new product development projects by providing international regulatory requirements assessing the impact of product changes and shaping regulatory strategies that support both compliance and business objectives. This role will support EU MDR technical documentation maintenance audit and inspection readiness and global quality system compliance by ensuring regulatory documentation remains current accurate and aligned with applicable international requirements and internal procedures.
The successful candidate will be a proactive detail-oriented regulatory professional who can work independently navigate complex global requirements influence cross-functional partners and help strengthen RA processes while supporting Medtronics Mission to improve patient access to life-changing therapies around the world.

Responsibilities may include the following and other duties may be assigned.

• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company internal audits and inspections.
• Develops and executes global regulatory strategies for new or modified products for assigned projects.
• Leads or compiles all materials required in submissions license renewal and annual registrations.
• Collaborate with business unit and geography regulatory affairs personnel to support marketing authorizations for assigned projects
• Recommends changes for labeling manufacturing marketing and clinical protocol for regulatory compliance.
• Participate and represent OUS regulatory function in sustaining and new product development projects to provide OUS regulatory requirements.
• Monitors and improves tracking / control systems.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.
• Partners with R&D Quality Clinical Manufacturing and Regulatory teams to collect review and maintain technical documentation required to support global registrations audits and inspections.
• Supports the Regulatory Affairs function during internal audits notified body audits and quality system inspections globally.
• Perform additional duties as assigned.

Must Have: Minimum Requirements

• Bachelors degree required
• Minimum of 4 years of relevant experience or advanced degree with a minimum of 2 years of relevant experience.

Nice to Have

• U.S. and international medical device regulatory submission experience including FDA EU and global market pathways.
• Experience supporting Class II medical device approvals registrations renewals and change notifications.
• Knowledge of international medical device regulations and standards including US FDA EU MDR ISO 13485 and ISO 14971.
• Experience assessing regulatory impact of product process labeling manufacturing clinical hardware software or design changes.
• Experience working with Geography RA partners international regulatory teams in-country affiliates and cross-functional business partners.
• Strong technical writing communication analytical organizational and project management skills.
• Ability to work independently manage multiple priorities and influence in a global matrixed environment.

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 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.

Join us in our mission to alleviate pain restore health and extend lifewhere your unique background and perspective are valued.

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):$92000.00 - $138000.00

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 insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple 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 matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital 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

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission to alleviate pain restore health and extend life unites a global team of 95000 passionate people.
We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab to the factory floor to the conference room every one of us experiments creates builds improves and solves. We have the talent diverse perspectives and guts to engineer the extraordinary.

Learn more about our business mission and our commitment to diversity here.

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 addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.