We are looking for a passionate Senior Regulatory Affairs Specialist who has experience developing global regulatory strategies in partnership with our business unit project teams and geography regulatory partners for 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 devices.  They will manage strategy meetings, submissions, and deficiency responses to ensure approval for new product entry and device changes.  They will also ensure global compliance, participate in 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 to identify, address, and resolve potential regulatory obstacles and compliance blocks throughout the product lifecycle. 

• Regulatory Intelligence & Mentorship: Maintain up-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, ensuring timely market approvals and compliance with applicable regulations 

Must Have: Minimum Requirements  

• Bachelor’s degree in a scientific discipline or equivalent with 4 years of relevant experience, or an advanced degree with 2 years of experience.    

Nice To Have  

• A minimum of 2 years of experience in medical device regulatory affairs. 
• Knowledge in global regulations, including ISO 13485, MDSAP, and MDR 
• 5-8 years of industry experience, with at least 2-3 years in regulatory, engineering, clinical, or quality roles.  
• Advanced degree in a scientific, engineering, or health discipline.  
• In-depth experience with global regulatory requirements, including MDR, ISO 14971, ISO 13485, MDSAP, and quality standards  
• History of successful international device submissions, including LATAM, APAC, and CEEMEA 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 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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Recruitment Fraud Alert

We are aware of phishing scams targeting job seekers. Please keep the following in mind: 

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. 

If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. 

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 AskHR@medtronic.com. 

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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 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) 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.