Product Labeling Specialist (Hybrid)

Position Summary

As the Labeling Project Specialist in our Plymouth, Minnesota location you will be responsible for the overall coordination, development and execution of Global Labeling Projects. You will provide project leadership and orchestration of labeling development activities interfacing with Marketing, R&D, Regulatory, Technical Communications, Legal, Package Engineering and site Operations.

This is a Hybrid position that requires onsite work in our Plymouth, Minnesota location with the option to work from home a few days per week during core business hours Monday through Friday. 

What You'll do as a Product Labeling Specialist

• Create and modify labeling for product labels, cartons, and other related materials ensuring that they meet all medical, legal, and regulatory requirements for medical devices and follow the established design format, labeling style guidelines and branding guidelines.
• Build sustainable relationships of trust through open and collaborative communications.
• Maintain positive and cooperative communications and collaborations with all levels of employees, customers, contractors, and vendors.
• Use information exchange, influence and active persuasion without direct exercise of command to gain cooperation of other parties.
• Support a cross-functional team collecting labeling content and translating it into functional label layouts utilizing labeling software. Work on commercialized and new product introduction labels and instructions for use (IFUs).
• Work with other functions to identify and resolve labeling inconsistencies with labeling material and requirements and to meet project objectives.
• Collaborate with label change request initiators to plan, prepare and submit complete and accurate change requests within a PLM system. While ensuring correct implementation strategy is applied.
• Manage multiple concurrent deadlines.
• Provide guidance to management in identifying/executing alternate strategies to facilitate or accelerate delivery.
• Communicate with internal and external customers and vendors regarding ongoing operations.
• Strive for continuous improvement and consistency in deliverables.
• Maintain knowledge of new developments in packaging and labeling technologies.
• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes and tasks and assignments.

The Experience, Skills and Abilities Needed

Required: 

• Bachelor’s degree in science-related discipline.
• Minimum of 2 years labeling experience.

• Experience with document management systems and  (PLM)  Product Label Management Systems such as Nice Label, Bartender, or similar systems. 

• Proficiency in MS Office applications such as Word, Excel, PowerPoint, and Outlook.

Preferred:

• Developing labeling for medical devices for FDA, global markets, and ISO standards.
• Experience in Adobe Creative Cloud Applications including InDesign and  Illustrator.
• Unique Device Identifiers (UDI) /Global Trade Item Numbers (GTIN) requirements.
• Knowledge of medical device regulations and standards relating to labeling and regulated documentation.

Other:

• Strong interpersonal skills to quickly build relationships with cross functional teams  and communicate effectively with other functional groups. 
• Ability to influence others and operate effectively with ambiguous situations.
• Customer orientation and ability to adapt/respond quickly and efficiently.
• Must be able to listen to the customer’s requirements, desires and concerns, and recommend solutions.
• Self-motivated and able to work independently with limited supervision, making informed decisions based on analysis.
• Action-oriented and customer-focused to deliver consistent, quality results.
• Ability to function well under pressure.
• Ability to multi-task, organize and judge priorities. While being flexible to balance day-to-day deliveries at the same time as unanticipated activities.
• High level of detailed accuracy.

What STERIS Offers

We value our employees and are committed to providing a comprehensive benefits package that supports your health, wellbeing, and financial future.

Here is just a brief overview of what we offer:

• Market Competitive pay
• Extensive Paid Time Off and added Holidays
• Excellent Healthcare, Dental and Vision benefits
• Long- and Short-Term Disability coverage
• 401(k) with a company match
• Maternity and Paternity Leave
• Additional add- on benefits / discounts for programs such as Pet Insurance
• Tuition Reimbursement and continuing education programs
• Excellent opportunities for advancement in a stable long-term career

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