Senior Regulatory Affairs Specialist

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

Job summary

Medtronic is seeking a Senior Regulatory Affairs Specialist to ensure compliance with regulatory requirements in the Neurovascular Operating Unit. This role involves managing submissions, maintaining product documentation, and collaborating with various departments. The ideal candidate will have a Bachelor's degree and significant experience in medical device regulatory affairs.

Benefits

Health, Dental, and Vision Insurance

401(k) plan with employer match

Tuition assistance/reimbursement

Paid time off

Qualifications

• Minimum of 4 years of relevant experience.
• Excellent technical knowledge of medical products.
• Detail-oriented with excellent written and oral communication skills.

Responsibilities

• Prepare regulatory submissions and ensure compliance with US and EU standards.
• Interface with engineering, quality, and clinical teams.
• Review promotional materials and maintain regulatory documentation.

Skills

Regulatory Compliance

Project Management

Technical Writing

Education

Bachelor's degree in Science or Engineering

Tools

Microsoft Office

Job description

Senior Regulatory Affairs Specialist page is loaded

Senior Regulatory Affairs Specialist

Apply locations Irvine, California, United States of America time type Full time posted on Posted 2 Days Ago time left to apply End Date: June 30, 2025 (18 days left to apply) job requisition id R33516 We anticipate the application window for this opening will close on - 30 Jun 2025

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.

A Day in the Life

The Sr Regulatory Affairs Specialist will play a key role in sustaining the current product portfolio. The Sr Specialist has responsibility for compliance with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions. Sustaining regulatory responsibilities include reviewing changes to ensure that regulatory requirements continue to be met, documenting “no file” decisions, reviewing promotional materials, submitting product changes and annual reports, and ensuring that our product technical documentation is current and accurate.

SENIORREGULATORY AFFAIRS SPECIALIST - NEUROVASCULAR

In the Neurovascular Operating Unit, we are committed to delivering meaningful innovation to advance stroke treatment. You can view more about the business and our products at: https://www.medtronic.com/us-en/e/neurovascular.html

Our goal as an operating unit is to ensure that we utilize the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.

Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident – we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.

Careers That Change Lives

The Sr Regulatory Affairs Specialist will play a key role in sustaining the current product portfolio. The Sr Specialist has responsibility for compliance with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions. Sustaining regulatory responsibilities include reviewing changes to ensure that regulatory requirements continue to be met, documenting “no file” decisions, reviewing promotional materials, submitting product changes and annual reports, and ensuring that our product technical documentation is current and accurate.

A Day In The Life

• Provide strategic input and technical guidance on regulatory requirements for product modifications

• Prepare Pre-Sub, IDE/IDE Supplement, PMA/PMA Supplement, 510(k) submissions and technical documents to support CE mark/MDR submissions.

• Manage multiple projects and prioritize tasks to meet project schedules

• Interface with engineering, quality, clinical, marketing, and other functions as needed to fulfill responsibilities

• Communicate with regulatory agencies and Notified Body and serve as regulatory liaison on the project team throughout the product lifecycle.

• Review promotional and advertising material

• Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards

• Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements

• Participate in internal and external audits as needed

• Maintain regulatory affairs documentation to support compliance with applicable regulatory requirements

• Perform other duties as assigned or required

Qualifications - External

Must Have; Minimum Requirements

• Bachelor's degree in Science or Engineering (or related field) from an accredited college or university required.

• Minimum of 4 years of relevant experience

• Or advanced degree with a minimum of 2years of experience in medical device regulatory affairs

This is not a remote position

Nice To Have

• 4 years of experience in medical device regulatory affairs

• Excellent technical knowledge of medical products and understanding of relevant procedures, practices, and associated medical terminology.

• RAPS Professional Certification (RAC)

• History of successful 510(k)/IDE/PMA device submissions and other worldwide submissions and clearances.

• Experience with FDA requirements, guidance documents, Medical Device Directive, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards

• Detail-oriented

• Ability to be flexible with changing priorities

• Excellent interpersonal skills to interface with project team members and able to contribute to the overall success of the team.

• Excellent written and oral communication, technical writing and editing skills.

• Excellent leadership, interpersonal and influencing skills.

• Ability to manage multiple projects

• Proficiency with Microsoft Office and software tools.

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.

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 - $138,000.00This 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

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 95,000+ 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 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.