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Job Title:  Product Labeling Group Leader-Conroe, TX

Req ID:  32597
Job Category:  Research & Development/Scientific

Conroe, TX, US, 77303

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.

Your Role

As a Product Labeling Group Leader, you will be responsible for leading the product labeling team, executing labeling projects, and ensuring label management follows all applicable policies and procedures.  In this role, 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. Our Conroe, Texas facility offers a dynamic, fast paced work environment with a family-oriented, supportive, team-based culture.

What You Will Do

  • Provides direction on label management processes and project prioritization and execution
  • Creates and modifies labeling for product instruction for use (IFU) documents, labels, 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.
  • Leads activities for new and updated labels from creation, through First Article Inspection (FAI) through the change control process.
  • Monitors changes in labeling regulations in the US and/or abroad and ensures that labeling meets all medical, legal, and regulatory requirements
  • Confers with label package change initiators to assess business needs, determine requirements and help to solve problems in an innovative, cost effective and timely manner
  • Ensures all requested projects have appropriate labeling resources assigned to enable on-time completion of project goals
  • Contributes to the development of solutions and best practices for labeling initiatives, including recommending activities involving legacy systems, process improvement, country-specific requirements, labeling standards and regulations, and labeling stakeholders
  • Communicates with vendors regarding ongoing labeling operationsWorks with outside vendors on content translations for labels and IFUs

What You Will Also Do

  • Demonstrates excellent technical expertise of STERIS products and technologies, product labeling, and engineering change processes
  • Responsible for the management, design, development and delivery of targets of one or more projects including providing leadership and direction to the project team
  • Participates on cross-functional project teams and establishes good working relationships within STERIS Corporation
  • Controls and manages numerous product labeling project tasks that culminate in release to production via the engineering change process
  • Determines and manages all project management activities, project priorities, resource allocation, and schedule planning. 
  • May have budget accountability for a department or function
  • Strives for continuous improvement and consistency in deliverables

What You Will Need to Be Successful

  • Bachelor's Degree in Science or Communication, or other relevant degree program, preferred.
  • Minimum of 3 years product labeling experience and project management experience for medical device or other regulated industry (or 7 years without a bachelor’s degree)
  • Proficiency with common content management tools and systems.
  • Experience with document management systems and Product Lifecycle Managment (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
  • Strong interpersonal skills
  • Excellent written and verbal communication skills
  • High level of detailed accuracy

What STERIS Will Offer You

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. We do this by providing competitive salaries, healthcare benefits, tuition assistance, paid time off, holidays, matching 401(k), annual merit, and incentive plans.  Join us and help write our next chapter.

#LI-MO1

 

STERIS is a leading provider of products and services that meet the needs of growth areas within Healthcare: procedures, devices, vaccines and biologics.  We exist to fulfill our MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD. STERIS is a $3B, publicly traded (NYSE: STE) company with approximately 16,000 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.

Req ID:  32597
Job Category:  Research & Development/Scientific

Conroe, TX, US, 77303


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