À propos de ce poste Senior Regulatory Affairs Specialist - Onsite chez Medtronic
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 Operating Unit develops technologies used in the treatment of acute ischemic stroke and other neurovascular conditions. The team partners across regulatory, quality, engineering, clinical, and commercial functions to maintain compliance throughout the product lifecycle and support regulatory pathways that enable continued access to innovative therapies in global markets.
This position is based onsite in Irvine, California. Team members are expected to work on-site at least 4 days per week to support cross-functional collaboration and the execution of regulatory activities. Travel is expected to be minimal.
The Senior Regulatory Affairs Specialist supports regulatory compliance and product lifecycle management activities for a portfolio of neurovascular medical devices. This role is responsible for evaluating product changes, preparing regulatory submissions, maintaining regulatory documentation, and providing regulatory guidance to cross-functional teams to support business objectives and market access requirements.
Primary Responsibilities
- Provide regulatory strategy and guidance for product modifications and lifecycle management activities.
- Prepare and submit Pre-Submission, Investigational Device Exemption (IDE), IDE Supplement, Premarket Approval (PMA), PMA Supplement, and 510(k) regulatory submissions.
- Support technical documentation development and maintenance for European Union Medical Device Regulation (EU MDR) compliance and CE Mark activities.
- Assess product, labeling, manufacturing, and process changes to determine regulatory impact and document regulatory decisions.
- Partner with engineering, quality, clinical, marketing, and other cross-functional teams to ensure regulatory requirements are incorporated throughout the product lifecycle.
- Serve as the primary regulatory representative with regulatory authorities and Notified Bodies, including support for agency interactions and responses.
- Review promotional and advertising materials for compliance with applicable regulatory requirements.
- Maintain regulatory records, procedures, and submissions while supporting internal and external audits as required.
Required Qualifications
- Bachelor's degree in Science or Engineering and 4+ years of medical device regulatory affairs experience; or an advanced degree and 2+ years of medical device regulatory affairs experience.
- Experience supporting U.S. Food and Drug Administration (FDA) medical device submissions and regulatory compliance activities.
- Experience managing multiple regulatory projects in a regulated medical device environment.
Preferred Qualifications
- Regulatory Affairs Certification (RAC).
- Experience with 510(k), Investigational Device Exemption (IDE), Premarket Approval (PMA), or international medical device submissions.
- Knowledge of European Union Medical Device Regulation (EU MDR), ISO 13485, and ISO 14971 requirements.
- Experience supporting global regulatory compliance and market access activities.
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.
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 [email protected].
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.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).The base salary range applies across the United States, excluding Puerto Rico and certain 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.
