Process Owner (BPO), Labeling

BD; United States; On-site; USD 155,000 - 258,000; Full time

Job summary

Join a forward-thinking company dedicated to advancing health through innovative medical technology. As a Labeling Business Process Owner, you will lead the development and maintenance of labeling processes, ensuring compliance with regulatory standards. Your expertise in medical device development and quality management will drive continuous improvement and collaboration across teams. This role offers a dynamic environment where you can grow and make a meaningful impact on health solutions. If you are passionate about quality and innovation, this is the opportunity for you!

Benefits

Medical Insurance

Dental Insurance

401k Plan

Flexible Work Options

Qualifications

• 8+ years of experience in Class I/II/III medical devices with a focus on labeling.
• Strong knowledge of FDA and ISO regulations related to medical device labeling.

Responsibilities

• Own and maintain labeling processes, ensuring compliance with regulations.
• Collaborate with stakeholders to enhance labeling programs and training.

Skills

Medical Device Development

Quality Management

Process Improvement

Technical Writing

Regulatory Compliance

Education

Bachelor's or Master's in Life Sciences

Experience with Hardware and Software Applications

Tools

FDA CFR 820.30

ISO 13485

EUMDR

Job description

Job Description Summary

We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

This position is a temporary assignment which will include benefits (such as medical, health, dental, 401k). Eligibility for these benefits will be based on eligibility requirements as determined by the BD Total Rewards policy. This position will support remediation activities within MMS and is anticipated to last approximately through March 31, 2026.

The Labeling Business Process Owner (BPO) is responsible for process development, continuous improvement, automation, tooling, and training related to labeling development and maintenance processes. This role requires applying quality management and engineering skills for medical devices, providing guidance and solutions to new product development teams, and ensuring products meet quality standards and regulatory requirements. The individual should have experience in design controls, process development, change management, and leveraging digital tools for process automation and risk management. The role may also involve compliance remediation and wider product development process projects.

Job Description Summary:

1. Applies medical device development expertise to lead the creation and maintenance of labeling processes.
2. Provides strategic and tactical direction to ensure consistent leadership for labeling processes.
3. Monitors regulatory trends and observations, implementing necessary changes across business units.
4. Participates in other QMS activities, including Design Control and Change Control processes.

Responsibilities:

In accordance with applicable laws, regulations, and company policies, this position is responsible for:

• Owning and maintaining the labeling process, including procedures, work instructions, templates, and tools.
• Collaborating with Product Development Process leadership, global labeling policy owners, and stakeholders to maintain a comprehensive labeling program.
• Developing and delivering training programs related to labeling.
• Participating in core product development and post-market business processes.
• Coordinating and reporting on project activities.
• Serving as subject matter expert on labeling topics.
• Leading continuous process improvements and partnering with stakeholders on initiatives.
• Ensuring consistent application of labeling activities across the Quality System elements.
• Monitoring audit outcomes and implementing process improvements.
• Working with standards committees to adapt to regulatory changes.
• Supporting regulatory inspections and audits.
• Engaging in cross-site and cross-functional communities to support and drive change.

Education and Experience:

• Bachelor's or Master's degree in life sciences, engineering, or related field; experience with hardware and software applications is preferable.
• Minimum 8 years in Class I/II/III medical devices, with specific experience in labeling.
• Proven knowledge of FDA CFR 820.30, CFR 820.801, ISO 13485, EUMDR, UDI, ISO 15223-1, and related regulations.
• Experience in establishing global Quality strategies and oversight.
• Strong background in labeling, product design, and development, with a good understanding of design control requirements.
• Ability to drive improvements and work effectively across cultures and regions.
• Excellent technical writing, communication, and influencing skills.
• Willingness to travel as needed.

We prioritize on-site collaboration, requiring a minimum of 4 days in-office per week, with flexibility for remote or field roles as indicated in the job posting.

Employment may be contingent upon proof of COVID-19 vaccination or testing, in accordance with company policies and local laws.

Why Join Us?

Join a team that values your contributions, encourages authenticity, and promotes growth. Help us reinvent the future of health and find purpose in the possibilities. Learn more at https://bd.com/careers

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not discriminate based on race, color, religion, age, sex, or other protected statuses.

Required Skills

Details not specified.

Optional Skills

Details not specified.

Primary Work Location: USA, CA - San Diego TC Bldg C&D

Salary Range: $155,900.00 - $257,300.00 USD annually