Sr. Regulatory Affairs Specialist Global Markets

We anticipate the application window for this opening will close on - 30 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

Across our global Neuroscience organization we advance care for some of medicines 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.

SENIOR REGULATORY AFFAIRSSPECIALIST -Global Markets(High-Risk Devices)

Neuromodulation

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.

Check us out on LinkedIn: Medtronic Brain Modulationand Pain Interventions

Pelvic Health

Our Pelvic Health Operating Unit advances care for patients living with bladder and bowel control conditions through targeted minimally invasive neuromodulation therapies including sacral and tibial solutions. Designed to modulate nerve pathways and restore communication between the brain and pelvic floor these programmable therapies deliver personalized treatment supported by strong clinical evidence and long-term outcomeshelping improve confidence independence and quality of life.

Check us out on LinkedIn: Medtronic Pelvic Health

Onsite

At Medtronic we bring bold ideas forward with speed and decisiveness to put patients first in everything we 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.

We are looking fora passionate Senior Regulatory Affairs Specialist whohas experience developing global regulatory strategiesin partnership withourbusiness unit project teams and geography regulatory partnersfor our innovative high-risk medical device portfolio.

Role Overview

The Sr. Regulatory Affairs Specialist develops global regulatory strategies and leads worldwide submissions for high-risk medical will manage strategy meetings submissions and deficiencyresponsesto ensure approval for new product entry anddevice will also ensure global complianceparticipatein audits and provide support to project teams.

Key Responsibilities

• Global Regulatory Strategy & Submissions: Partner with business unit and geography regulatory teams to develop and execute global submission strategies deficiency responses and product registration plans for new and modified products.

• Product Lifecycle Management: Provide regulatory assessments and approvals for engineering change orders labeling changes and product releases to ensure continuous compliance across global markets.

• Agency Interaction & Compliance: Act as a key liaison to international regulatory agencies at the reviewer level; support manufacturing site registrations audits post-market vigilance and product recalls.

• Cross-Functional Technical Support: Collaborate with R&D engineering and supply chain teams toidentify address and resolve potential regulatory obstacles and compliance blocks throughout the product lifecycle.

• Regulatory Intelligence & Mentorship: Maintainup-to-date knowledge of global regulations and industry standards to inform company strategy; provide guidance and training to junior team members.

• Strategic Focus: Lead the strategic direction and planning for global regulatory projects ensuringtimelymarket approvals and compliance with applicable regulations

Must Have:MinimumRequirements

• Bachelors degree ina scientificdiscipline or equivalent with4 yearsof relevant experience or an advanced degree with2 yearsof experience.

Nice To Have

• A minimum of 2 years of experience in medical device regulatory affairs.
• Knowledge inglobal regulations including ISO 13485 MDSAP and MDR
• 5-8 years of industry experience with at least 2-3 years in regulatoryengineeringclinical or quality roles.
• Advanced degreein a scientificengineering orhealth discipline.
• In-depth experience withglobalregulatory requirementsincludingMDR ISO 14971 ISO 13485MDSAPand quality standards
• History of successful international device submissions includingLATAM APAC andCEEMEA regions
• Experience with Class III medical devices (PMA)

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 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:

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.

If you are applying to perform work for Medtronic Inc. (Medtronic) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County you can find a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

Required Experience:

Senior IC