Labeling Specification Specialist
About The Position
The Labeling Specification Specialist is responsible for the design, development, testing, deployment, and ongoing support of labeling database applications used in a regulated medical device environment. The position ensures labeling systems are accurate, validated, and compliant with medical device regulations by maintaining commercial applications, creating and managing labeling product families, participating in design reviews, and documenting work according to established quality standards. The incumbent also conducts software validation testing, prepares test reports, and follows internal software development, cybersecurity, and compliance procedures to support product quality and regulatory requirements. 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 onsite 4 days a week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. In your role, you may work from the following Medtronic sites: Mounds View, Minnesota Santa Ana, California This role will require 5% of travel to enhance collaboration and ensure successful completion of projects.
Requirements
- Requires a Bachelor's degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
- 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.
- 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.
- Candidates below the Principal level require unrestricted U.S. work authorization at the time of hire and for the duration of employment.
Nice To Haves
- Previous Medtronic experience
- Loftware Spectrum
- Skills with Adobe CS3 (or later) publishing suite of software
- Ability to use computers and other graphic-arts related technology
- Ability to manage structured content (such as HTML, XML)
Responsibilities
- Design, develop, test, deploy and maintain software applications.
- 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.
Benefits
- 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
- Simple Steps (global well-being program)
- 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)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Principal
