Job Description

We anticipate the application window for this opening will close on - 13 Apr 2026

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

Onsite

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. We're working onsite 4 days a week to drive performance, foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary.

The Regulatory Affairs Specialist (RAS) develops and executes strategies for global regulatory approvals to introduce new and modified medical devices to the market. The RAS translates regulatory requirements into project/product requirements, prepares regulatory submissions, and negotiates their approval with regulatory agencies as required.? Primary responsibilities include: developing global regulatory strategies; preparing US, EU and international regulatory submissions; providing documentation for international submissions; supporting post-market regulatory compliance activities; evaluating proposed product changes for regulatory impact, all while ensuring timely and high-quality execution of assigned regulatory deliverables.

This role primarily focuses on regulatory support for the US and EU markets, with a wide variety of regulatory tasks to allow you to make the most of your existing knowledge base while growing your RA skill set every day. In this role, you will have primary RA responsibility for multiple Class II and/or Class III products, working within a collaborative team environment that fosters professional development while focusing on meeting business objectives with excellence.

From developing and authoring regulatory submissions to providing critical input on cross-functional development project teams, this role is an excellent opportunity for the right regulatory professional to take their career to the next level at the world's leading medical device company.

Position Responsibilities

• Supportscoordinating the planning, preparation, assembly,reviewand publication of regulatory submissions to the FDA and other worldwide government agencies. Able to write regulatory justifications to support submission filing decisions.

• Supportscompiling and producingmaterials required in submissions, licenserenewaland annual registrations.

• Ensure regulatory submissions areaccurateand verifiable against source documents to confirm compliance and traceability.

• Supports interactionswith regulatory authorities during the development and review process to ensuresubmissionapproval.

• RA Representative oncross functionalproject teams to communicate regulatoryrequirements, perform regulatoryassessmentsand prepareregulatory documentationaccording to a defined timeline.

• Perform regulatory assessments on product changesthat may beinitiatedinternally or externally.

• Recommendchanges for labeling, manufacturing, marketing, and clinicaldocumentationfor regulatory compliance.

• Review and approveengineering change ordersper company procedures, toassurecompliance with regulatory requirements.

• Work with global regions to solve internal regulatory blocks within the supply chain.

• Creation and/or maintenance of Technical Document, GSPRs, Declaration of Conformity, Risk Classification Assessments.

• Review and assessimpactof NCMRsin a timely mannerto support manufacturinggoals.

• Maintain current knowledge of the development and changes to applicable laws,regulationsand industry standards, andassistin the dissemination of this information to theappropriate individualswith the company.

• Anticipate regulatory obstacles and emerging issues throughout the product lifecyclemaintenanceand develop solutions with other members of regulatory and related teams.

• Participation in internal and external audit preparedness.

• Other duties as assigned.

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Minimum Requirements:**

• Bachelor's DegreeinEngineering, Life Sciences, or related medical/scientific/technical area of focuswith2+ years ofrelatedexperience, or a Masters degree with 0 years of experience.

Desired/Preferred Qualifications

• Understanding of engineering concepts and scientific terminology

• Ability to understand, evaluate, and provide guidance on scientific literature, reports, and rationale

• Experience reviewing technical and designspecifications

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

• Superior interpersonal skills

• Excellent analytical thinking skills

• Ability to effectively manage multiple projects and priorities

• Proven ability to work effectively in cross-functional teams

• Excellent written and verbal communications skills

• Strong organization and time management skills

• Presentation skills for small to mid-sized groups

• Detail-oriented

• Ability to be flexible with changing priorities

• Submission-related word processing skills

• Some overnight travelrequired

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.

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):$73,600.00 - $110,400.00

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 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 ( name=signon&co\ num=30601&co_affid=medtronic)

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.

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.

We change lives . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.

We build extraordinary solutions as one team . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.

This life-changing career is yours to engineer . By bringing your ambitious ideas, unique perspective and contributions, you will...

• Build a better future, amplifying your impact on the causes that matter to you and the world

• Grow a career reflective of your passion and abilities

• Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning

These commitments set our team apart from the rest:

Experiences that put people first . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.

Life-transforming technologies . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.

Better outcomes for our world . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.

Insight-driven care . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care

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.

For sales reps and other patient facing field employees, going into a healthcare setting?is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .

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Job Tags

H1b, Work at office, Local area, Worldwide, Flexible hours, Night shift

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