Labeling Specification Specialist

About the role

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.

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.
• Maintains and monitors changes in labeling regulations in the US and/or abroad.
• Reviews promotional and commercial communication material and ensures 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.

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.

Qualifications

• Nice to Have (Preferred Qualifications): Previous Medtronic experience, Loftware Spectrum skills, Ability to use computers and other graphic-arts related technology, Ability to manage structured content (such as HTML, XML).

Benefits

Competitive Salary and flexible Benefits Package including 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).

Pay

$73,600.00 - $110,400.00

Schedule

4 days a week onsite, with 5% travel to enhance collaboration and ensure successful completion of projects.