Sr Regulatory Affairs Spec

Sr. Regulatory Affairs Specialist

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

• Bachelor's 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 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.

Join us in our mission to alleviate pain, restore health, and extend life—where your unique background and perspective are valued.

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):$92,000.00 - $138,000.00This 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.

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 here 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.