Technical Communication Specialist & Labeling Designer - Medical Devices (On Site)

Medtronic; Irvine (CA); On-site; USD 68,000 - 102,000; Full time

Job summary

Medtronic Irvine, CA is seeking a Tech comm Specialist/ Writer to develop labeling and regulatory documentation for Neurovascular products. You will define labeling strategy, manage translation, and oversee PLM changes while ensuring compliance with 21 CFR, EU MDR, ISO standards and Medtronic quality systems.

The role requires at least 2 years in regulatory/product compliance, labeling, or technical writing in medical devices, with strong written communication skills and the ability to work

Qualifications

• Requires a Baccalaureate degree.
• Minimum of 2 years of regulatory/product compliance, labeling, technical writing, or technical editing experience in the medical devices industry.

Responsibilities

• Develop, maintain, and release labeling and technical documentation for Neurovascular products.
• Collaborate with product development and cross-functional partners to define labeling strategy.
• Coordinate translation projects and manage translation requirements.
• Handle change control and admin tasks in a Product Lifecycle Management system.
• Apply US/EU regulations (21 CFR, EU MDR, ISO standards) and quality systems.
• Perform quality checks and proofreading of artworks.
• Manage documentation in a matrixed environment and prioritize tasks.
• Travel domestically and internationally as needed (<10%).

Skills

Regulatory compliance

Technical writing

Labeling

Technical editing

Education

Baccalaureate degree

Job description

Onsite

Irvine, California, United States of America

Full time

R70985

We anticipate the application window for this opening will close on - 24 Oct 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

Across our global Neuroscience organization, we advance care for some of medicine’s most complex neurological and spinal conditions. By combining innovative technology, data-driven insights, and deep clinical expertise, we partner with physicians and health systems to improve how patients are treated and supported throughout their care journey.

Our Neurovascular operating unit advances treatment of stroke, brain aneurysms, and vascular disorders through innovative endovascular technologies. With devices designed for revascularization, embolization, and precise intervention, we support clinicians in delivering timely, effective care for complex neurovascular conditions.

Check us out on LinkedIn: Medtronic Neurovascular (https://www.linkedin.com/showcase/medtronic-neurovascular/posts/?feedView=all)

Responsible for developing, maintaining, and releasing labeling and technical documentation for Neurovascular products, including all preprinted labeling, Instructions for Use, user guides, system manuals, quick reference guides, package inserts, label stocks, and other related technical literature. Collaborates with product development and cross-functional partners to define labeling strategy, gather labeling requirements, communicate complex information clearly, create plans to support document release activities, and coordinate translation projects.

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

Responsibilities may include the following and other duties may be assigned.

• The Tech comm Specialist/ Writer responsible for developing regulatory tech comm and labeling strategy. Create plans to support document release activities from start to end.
• Identify IFU/labeling requirements and obtain necessary content information from various sources.
• Learn and understand the design and behavior of the company’s products.
• Design, develop, and maintain IFU/labeling using Adobe InDesign and other software applications. Control IFU/labeling versioning and maintain the IFU archives.
• Identify IFU/labeling translation requirements, prepare and manage translation projects to completion.
• Manage change control and perform the administrative documentation tasks required to establish and track IFU/labeling in a Product Lifecycle Management system.
• Understands and applies relevant US and EU regulations, standards, and guidance documents (e.g., 21 CFR, EU MDR, IMDRF, ISO20417, ISO15223, and ISO 10555), as well as Medical Device Quality Systems (e.g., ISO 13485) and Risk tools (e.g., ISO 14971)
• Continuously evaluate business processes, identify improvement opportunities, and implement improvements.
• Perform quality checks and proofread the artworks.
• The Tech comm Specialist/ Writer is expected to complete projects independently, manage their own priorities, apply company procedures to resolve issues, identify and pursue improvement projects, and may be required to manage the user documentation pool for a specific business segment or segments.
• The Tech comm Specialist/ Writer is expected to manage within a matrixed environment, where direction, prioritization of work, and other daily activities may be established via an indirect reporting relationship.
• Occasional domestic and international travel may be required.
• All activities must be performed in compliance with the Quality System.
• Performs duties in compliance with environmental, health, and safety-related site rules and policies.
• All other duties as assigned.
• Travel requirement: Less than 10%

Required Knowledge and Experience:

• Requires a Baccalaureate degree
• Minimum of 2 years of regulatory/product compliance, labeling, technical writing, or technical editing experience in the medical devices industry.

Nice to Have

• Advanced experience with Structured Authoring using XML and content management solutions(CMS).
• Advanced Experience with Adobe Acrobat® and PhotoShop® software, vector graphics software (e.g. Adobe Illustrator®) and HTML.
• Experience writing for a global audience.
• Experience with CMS

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):$68,000.00 - $102,000.00

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 (https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic)

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 (https://www.medtronic.com/content/dam/medtronic-wide/public/united-states/employee-support-services/careers/la-county-legal-notice.pdf) 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.

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

For sales reps and other patient facing field employees, going into a healthcare settingis 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 (https://www.e-verify.gov/employees) .

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