Senior Regulatory Affairs Specialist

Regulatory Jobs; Irvine (CA); On-site; USD 92,000 - 138,000; Full time

Benefits offered by this job

Health, Dental and Vision insurance

401(k) with match

Paid time off

Tuition assistance

Job summary

Medtronic’s Neurovascular Regulatory Affairs team in Irvine, CA, seeks a Senior Regulatory Affairs Specialist to support regulatory data governance, processes, and systems. This onsite role collaborates across product development, quality, labeling, clinical, and commercial functions to ensure global regulatory compliance and data integrity.

Responsibilities include governance, standard assessments, UDI coordination, and cross-functional project leadership, with opportunities to leverage

Qualifications

• Bachelor's degree with 4+ years in regulatory affairs, quality, standards, or medical device experience (or advanced degree with 2+ years).
• Experience coordinating standards assessments with Regulatory Affairs and cross-functional subject matter experts.
• Experience evaluating regulatory impacts and maintaining compliance documentation.
• Experience working in regulated medical device environments.

Responsibilities

• Serve as a subject matter expert for regulatory data and regulatory systems across the Neurovascular portfolio.
• Manage regulatory data governance activities, including data quality reviews and remediation efforts.
• Coordinate Unique Device Identification (UDI) activities and maintain device registration data.
• Lead standards gap assessment processes and track actions to completion.
• Coordinate regulatory change assessments across products, regions, and systems.
• Lead or support cross-functional regulatory projects involving multiple products or teams.
• Support implementation, testing, validation, migration, and verification of regulatory systems and digital solutions.
• Partner with stakeholders to implement process improvements, automation opportunities, and AI-enabled regulatory initiatives.

Skills

Regulatory data governance

Project management

Cross-functional collaboration

Data integrity

Education

Bachelor's degree or higher in life sciences or related field

Advanced degree in related field

Tools

Regulatory information management systems

Job description

We anticipate the application window for this opening will close on - 21 Nov 2026

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

The Neurovascular business within Medtronic develops technologies that support the treatment of stroke and other neurovascular conditions. The Regulatory Affairs organization partners across product development, quality, labeling, clinical, and commercial functions to ensure global regulatory compliance and product availability. This role supports regulatory data governance, regulatory process ownership, standards assessments, digital transformation initiatives, and cross-portfolio projects that impact multiple products and regulatory systems across the Neurovascular portfolio.

Check us out on LinkedIn: Medtronic Neurovascular.

This position is based in Irvine, California, and follows an onsite work model. No travel is required.

The Senior Regulatory Affairs Specialist serves as a regulatory subject-matter expert supporting regulatory data integrity, regulatory process excellence, standards assessments, and the implementation of regulatory systems and digital solutions. This role works across multiple product portfolios and regulatory functions to improve data quality, support regulatory initiatives, coordinate cross-functional assessments, and ensure regulatory information is maintained accurately across business systems.

Primary Responsibilities

• Serve as a subject matter expert for regulatory data, related business processes, and regulatory systems across the Neurovascular portfolio.
• Manage regulatory data governance activities, including data quality reviews, discrepancy resolution, remediation efforts, and continuous improvement initiatives.
• Coordinate Unique Device Identification (UDI) activities and partner with Regulatory Affairs, Labeling, and cross-functional teams to maintain accurate device registration data.
• Lead standards gap assessment processes, including assignment, tracking, documentation, stakeholder coordination, and completion of required actions.
• Coordinate regulatory change assessments and evaluate potential impacts across products, regions, registrations, and regulatory systems.
• Lead or support cross-functional regulatory projects involving multiple products, product families, or regulatory teams.
• Support implementation, testing, validation, migration, reconciliation, and verification activities for regulatory systems and digital solutions.
• Partner with business and corporate stakeholders to implement process improvements, automation opportunities, and AI-enabled regulatory initiatives.

Required Qualifications

• Bachelor's degree and 4+ years of regulatory affairs, quality, standards, or medical device experience OR Advanced degree and 2+ years of regulatory affairs, quality, standards, or medical device experience.
• Experience managing projects, processes, or initiatives involving multiple stakeholders, products, or regulatory systems.
• Experience coordinating standards assessments and driving actions to completion with Regulatory Affairs and cross-functional subject matter experts.
• Experience evaluating regulatory impacts and maintaining compliance-related documentation, data, or business processes.
• Experience working within regulated medical device environments.

Preferred Qualifications

• Experience with Unique Device Identification (UDI), global device registrations, EUDAMED, regulatory information management systems, or data governance.
• Experience supporting digital transformation, automation, analytics, or AI-enabled initiatives in a regulated environment.
• Experience assessing the regulatory impact of standards updates across product portfolios and supporting related change assessments.
• Experience leading cross-functional projects involving regulatory systems, process improvements, or enterprise initiatives.
• Knowledge of global medical device regulatory requirements, registrations, and product lifecycle management processes.

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.

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):$92,000.00 - $138,000.00

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 pertain 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, andSimple Steps (global well-being program).

• 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
• 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), andCapital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

• 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)
• 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.