Manager, Instructional Labeling

Requisition ID: 34062

At Terumo Blood and Cell Technologies, our 7,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world. For Terumo, for Everyone, Everywhere.

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient's life every second of every day and are committed to continuing to increase the number of patients we serve. Advancing healthcare with heart.

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Join us and help shape wherever we go next. You create your future and ours.

We're seeking a Manager of Instructional Labeling and Content to lead a team of skilled technical writers in developing a wide range of instructional materials for regulated medical devices and software-including Instructions for Use (IFUs), operator manuals, quick reference guides, installation guides, and electronic labeling (eIFUs). In this pivotal role, you'll oversee content strategy, ensure alignment with global regulatory standards, and drive innovation in digital content delivery. You'll also guide the team in leveraging a component content management system (CCMS) and structured authoring tools (e.g., DITA, Oxygen XML) to produce modular, reusable content that supports global scalability and localization. If you're ready to lead cross-functional collaboration and elevate the quality and impact of instructional labeling, we want to hear from you.

ESSENTIAL DUTIES

• Hire, develop, and manage a high-performing team of content developers including responsibility for onboarding, performance management, professional development, and coaching to ensure team and individual growth.
• Provide guidance to content developers responsible for creating, reviewing, and maintaining customer-facing instructional content across the product lifecycle.
• Forecast and meet project deadlines and budgets taking the initiative to report on project status to leadership and internal stakeholders.
• Mentor the content development team by providing guidance in instructional labeling best practices, project management practices, and design controls.
• Provide strategic input related to instructional labeling based on business and market strategies.
• Own the content strategy and information architecture for IFUs and operator manuals, and other technical content.
• Ensure all instructional labeling materials meet regulatory and country-specific requirements (e.g., FDA 21 CFR Part 801, EU MDR, ISO 20417, UDI, etc.).
• Drive continuous process improvement initiatives related to content quality, process efficiencies, digital formats (eIFU, XML), and accessibility.
• Provide guidance and direction for customizing and maintaining our component content management system (CCMS).
• Support audits and regulatory inspections as the instructional labeling subject matter expert.
• Monitor evolving global labeling and content requirements, interpreting their impact on company processes and content.

MINIMUM QUALIFICATION REQUIREMENTS

Education

Bachelor's degree in Technical Communication, Life Sciences, Engineering, Communications, or related field or equivalent education and experience sufficient to successfully perform the essential functions of the job may be considered

Experience

Minimum 7 years of experience, with at least 5 years of leadership experience in instructional content, labeling, or technical communication in a regulated industry (preferably medical device or medical software products).

Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.

Skills

• Deep knowledge of applicable global labeling regulations and standards.
• Experience effectively managing multiple projects with changing priorities in a dynamic, regulated environment.
• Experience working within a Product Lifecycle Management (PLM) system and authoring tools, e.g. DITA, Oxygen XML and a component content management system (CCMS).
• Experience with eIFU programs and electronic labeling strategies (eIFU, QR code integration).
• Strong leadership, project management skills, including resource planning and budgeting.
• Strong attention to detail
• Ability to work independently and collaboratively with colleagues at all levels of the organization.
• Excellent written, verbal, and interpersonal communication skills.

LOCATION

Lakewood, Colorado or Remote - Open to candidates willing to relocate to the area.

PHYSICAL REQUIREMENTS

• Typical office environment requirements include reading, speaking, hearing, close vision, walking, bending, sitting and occasional lifting up to 20 pounds.
• The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Target Pay Range:$123,200.00to$154,000.00 -Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data

Target Bonus on Base:15.0%

At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family.Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more.To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates.For us, it's about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.

• Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan.
• In 2019, Terumo Blood and Cell Technologies reached $1 billion in revenue.
• We employ nearly 7,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.
• We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries.
• Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare.
  
  
  
  • Respect - Appreciative of others
  • Integrity - Guided by our mission
  • Care - Empathetic to patients
  • Quality - Committed to excellence
  • Creativity - Striving for innovation
  
  
  
  
• We contribute to the Leukemia and Lymphoma Society (LLS), raising $1.3 million USD since 2007.

We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.

Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment.Our Colorado campus locations are tobacco-free workplaces, and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification.