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Labeling Specification Specialist

We anticipate the application window for this opening will close on - 2 Apr 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

A career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide. 

A Day in the Life

In this exciting role as a Labeling Specification Specialist , you will be responsible for supporting the development of medical device labeling for the Structural Heart and Aortic, Peripheral Vascular Health and Coronary and Renal Denervation businesses by coordinating across functions as well as with multiple US and international sites. You will provide project support and orchestration of labeling development activities interfacing with Marketing, R&D, Regulatory, Technical Communications, Legal, Quality and Package Engineering, site Operations, and other relevant business partners.

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

  • Creates, reviews, and reproduces text required for labeling medical products.

  • Ensures that labeling, art, film, and plate proofs meet all medical, legal, and regulatory requirements.

  • Monitors changes in labeling regulations in the US and/or abroad.

  • Reviews promotional and commercial communication material and ensures that it is supported by the data and consistent with the application.

  • Monitor, evaluate and recommend improvements to labeling processes, quality, systems tools and/or policies.

Minimum Requirements: 

  • Bachelor's degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.

  • Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.

Nice to Have:

  • Familiarity with relevant regulations and standards for the specific industry (e.g., medical devices, pharmaceuticals) is crucial. 

  • Accuracy and precision are essential for ensuring the correctness of labeling content and specifications. 

  • The ability to communicate effectively with cross-functional teams is important for coordinating labeling activities. 

  • The ability to identify and resolve labeling-related issues is necessary. 

  • Familiarity with labeling design software and other relevant software is often required. 

  • Experience in Quality Assurance or Produce Development preferred. 

  • Previous experience in Labeling Specifications preferred.

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):$80,000.00 - $120,000.00

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 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.

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Average salary estimate

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What You Should Know About Labeling Specification Specialist, Medtronic

At Medtronic, we believe in creating a more connected and compassionate world through our innovative healthcare solutions. As a Labeling Specification Specialist based in Santa Rosa, California, you’ll play a crucial role in more than just the labeling of medical devices; you’ll be supporting the Structural Heart, Aortic, Peripheral Vascular Health, and Coronary and Renal Denervation businesses. In this position, you'll collaborate with numerous teams, ensuring that our labeling meets stringent medical, legal, and regulatory requirements while also representing the high standards of Medtronic. You'll create and review labeling text, monitor changing regulations, and conduct thorough evaluations of processes to suggest improvements. With your expertise, you'll coordinate among Marketing, R&D, and Quality teams—as well as engage with international sites—to orchestrate the development of clear, compliant, and accurate labeling specifications. Your role may require you to keep your finger on the pulse of industry regulations and confidently communicate complex information. At Medtronic, we value precision and clarity, so your attention to detail will be paramount. Whether you are fresh out of an advanced degree or bring years of relevant experience, your voice matters. We are excited to offer competitive compensation, a robust benefits package, and a chance to develop a rewarding career. Join us and be a part of a mission to alleviate pain, restore health, and extend life for millions worldwide. This is more than just a job; it’s a commitment to making a profound difference in healthcare access and equity for everyone.

Frequently Asked Questions (FAQs) for Labeling Specification Specialist Role at Medtronic
What are the responsibilities of a Labeling Specification Specialist at Medtronic?

As a Labeling Specification Specialist at Medtronic, your key responsibilities include developing and reviewing labeling for medical devices, ensuring that all materials meet medical, legal, and regulatory requirements. You'll need to collaborate with multiple teams during the labeling development process and monitor changes in regulations both domestically and internationally.

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What qualifications are required for the Labeling Specification Specialist position at Medtronic?

To qualify for the Labeling Specification Specialist role at Medtronic, you should hold a Bachelor's degree with a minimum of two years of relevant experience, or an advanced degree with no prior experience. Familiarity with medical device regulations and effective cross-functional communication skills are also important for this position.

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What skills are essential for a successful Labeling Specification Specialist at Medtronic?

Essential skills for the Labeling Specification Specialist at Medtronic include accuracy and attention to detail in labeling content, proficiency in labeling design software, and the ability to tackle and resolve any labeling-related issues that may arise. Strong communication skills with cross-functional teams are crucial as well.

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What types of projects do Labeling Specification Specialists work on at Medtronic?

Labeling Specification Specialists at Medtronic work on projects that involve the creation and validation of labeling for a variety of medical devices across several specialties, including Structural Heart and Peripheral Vascular Health. Your role will require coordination among diverse teams, ensuring consistency and compliance throughout the labeling lifecycle.

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How does Medtronic support career development for Labeling Specification Specialists?

Medtronic strongly supports career development for Labeling Specification Specialists through comprehensive training programs, access to mentorship opportunities, and a commitment to internal advancement. You’ll be encouraged to propose improvements to labeling processes, fostering a culture of innovation and continuous growth.

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Common Interview Questions for Labeling Specification Specialist
How do you ensure accuracy in labeling for medical devices?

To ensure accuracy in labeling, I meticulously review all content against regulatory standards and collaborate closely with teams to validate information. I also implement a checklist system to catch any discrepancies before finalizing the labeling.

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Can you describe a time you had to coordinate across multiple teams for a project?

In a previous role, I led a project where I coordinated efforts between Marketing, R&D, and Quality teams to develop a labeling system for a complex device. Regular communication and scheduled meetings helped keep everyone aligned on the project’s goals.

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What experience do you have with labeling design software?

I have hands-on experience with various labeling design software, including Adobe Illustrator and specialized medical device labeling software. I am proficient in creating professional layouts that comply with industry regulations.

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How do you stay updated on changes in labeling regulations?

I stay updated on labeling regulations by subscribing to industry newsletters, attending relevant webinars and conferences, and participating in professional networks that focus on medical device compliance.

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What role does teamwork play in your process as a Labeling Specification Specialist?

Teamwork is vital in my role as it facilitates collaboration with various departments to ensure that all aspects of labeling are coherent and compliant. It is through teamwork that we can identify challenges early and implement effective solutions.

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How do you handle conflicts or disagreements during labeling projects?

When faced with conflicts, I prioritize open communication. I listen to differing viewpoints and strive for compromise while focusing on our ultimate objective of compliance and quality in labeling.

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What strategies do you use to monitor labeling effectiveness?

To monitor labeling effectiveness, I employ feedback loops from the Sales and Marketing teams to gauge customer understanding and compliance, as well as periodic audits of our labeling processes for ongoing improvement.

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Why do you want to work at Medtronic as a Labeling Specification Specialist?

I am drawn to Medtronic's commitment to innovation and improving patient outcomes. Being part of a team that directly contributes to life-extending solutions is a motivating factor for me.

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What do you believe are the most crucial attributes for a Labeling Specification Specialist?

I believe that the most crucial attributes for a Labeling Specification Specialist include attention to detail, strong communication skills, and the ability to adapt to regulatory changes efficiently to maintain compliance.

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Can you discuss your experience with quality assurance in labeling processes?

In my previous role, I was responsible for quality assurance checks within the labeling process which involved reviewing proofs and conducting audits to ensure all materials met both internal and external standards before approval.

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