Senior Product Labeling Specialist

Location

Mentor, OH | United States

Job description

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

Position Summary

As a Sr. Product Labeling Specialist, you will work within Product Engineering with the crucial responsibility for the design, development, approval, and implementation of all product labelling on new and sustaining projects.

This position is considered a Hybrid role - Minimum 4 days onsite at our Mentor, Ohio Headquarters is required. 

Duties

You will interface with domestic and international Regulatory Affairs, Quality, Product Managers, New Product Development, Clinical Affairs, Purchasing, Manufacturing/Production, Information Technology, and Packaging Engineering and will be responsible for the labelling management for STERIS Endoscopy – Mentor, OH. In this role you will work closely with Regulatory Affairs to ensure compliance with domestic and international regulations. Additionally, the position includes working with multiple vendors (including translation services and print suppliers) and program management for all labelling projects. Other responsibilities include:

• Create and modify labels, product instruction for use (IFU) documents, label cartons, and other related materials ensuring that they meet all medical, legal, and regulatory requirements for medical devices following the established design format, labeling style guidelines, and branding guidelines. 
• Control and manage numerous product labeling project tasks that culminate in release to production via the engineering change process.
• Lead activities for new and updated labels from creation, through First Article Inspection (FAI) through the change control process and provides direction on the label management processes.
• Monitor changes in labeling regulations in the US and/or abroad and ensures that labeling meets all medical, legal, and regulatory requirements.
• Confer with label change initiators to assess business needs and to determine their requirements to help solve problems in an innovative, cost effective, and timely manner ensuring all requested projects are planned and prioritized appropriately to meet project goals.
• Contribute to the development of solutions and best practices for labeling initiatives, including recommending activities involving legacy systems, process improvements, country-specific requirements, labeling standards and regulations, and labeling stakeholders.
• Interface with other Labeling Specialists at STERIS especially with the Conroe, TX team to ensure processes and requirements are aligned.
• Work with outside vendors on content translations for labels and IFUs.
• Demonstrate excellent technical expertise of STERIS products and technologies, product labeling, and engineering change processes.
• Work with IT, manufacturing, and document control personnel to set label printer parameters. Work with this same team to troubleshoot issues and establish processes that eliminate issues.
  

Required Experience

• Bachelor’s degree, in science or communication related field.
• Minimum of 3 years product labeling experience for medical device or other regulated industry.
• Minimum of 3 years’ experience and proficiency with common content management tools and systems – NiceLabel and NiceLabel Cloud preferred.
• Minimum of 3 years’ experience with Regulatory requirements.
• Proficiency with common content management tools and systems.
• Experience with document management systems (PLM) 
• Technical writing proficiency highly desirable with emphasis on medical device product labeling development, experience in working within a regulated industry.
• Self-motivated and able to work independently with limited supervision, making informed decisions based on analysis.
• Knowledge of medical device regulations and standards relating to labeling and regulated documentation.
• Customer service oriented with the ability to build cross-functional relationships with internal and external personnel
• Excellent tech writing, copy editing and written and verbal communication skills. 
• High level of detailed accuracy.
• Flexibility to accommodate changing priorities, deadlines and project needs. 

What STERIS offers:

The opportunity to join a company that will invest in you for the long-term. STERIS couldn’t be where it is today without our incredible people. That’s why we share in our success together by rewarding you for your hard work. Hiring people who are in it for the long run with STERIS is our ultimate goal.  Join us and help write our next chapter.

Here is just a brief overview of what we offer:

• Competitive Pay
• Extensive Paid Time Off (18 days starting) and (9) added Holidays.
• Excellent healthcare, dental, and vision benefits
• 401(k) with a company match
• Long/Short term disability coverage
• Parental Leave
• Additional add-on benefits/discounts for programs such as Pet Insurance
• Continued training and educations programs
• Tuition Assistance
• Excellent opportunities for advancement in a stable long-term career
• Hybrid working in select roles, teams, and functions.

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STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention.  WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare, life sciences and dental products and services. STERIS is a $5 billion, publicly traded (NYSE: STE) company with approximately 17,000 associates and Customers in more than 100 countries.

If you need assistance completing the application process, please call 1 (440) 392.7047 . This contact information is for accommodation inquiries only and cannot be used to check application status.

STERIS is an Equal Opportunity Employer.  We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law.  We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.

The full affirmative action program, absent the data metrics required by § 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location’s HR Office during normal business hours.

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