We are the people who give possibilities purpose

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.

Job Description

The Advanced Patient Monitoring Regulatory Affairs team is seeking a detail-oriented and proactive Regulatory Affairs Specialist to support global product distribution and ensure ongoing regulatory compliance. This role is responsible for maintaining high‑quality regulatory and product data across internal systems, enabling compliant global commercialization and lifecycle management.

Role Overview

This role is responsible for managing product data attributes, certificates, and country‑specific compliance requirements within internal product data management, distribution‑control, and regulatory information management systems. You will ensure products meet all applicable regional regulatory requirements and that accurate, validated data supports global commercialization activities, including submissions to regulatory databases such as GUDID and EUDAMED. This role operates with moderate autonomy, applies regulatory data expertise, and collaborates across multiple functions to support efficient and compliant business operations.

In this position, you will maintain accurate product and regulatory data to safeguard global distribution and ensure adherence to local, regional, and international regulatory standards. The role requires close collaboration with cross‑functional teams, including Master Data Management, Corporate and Business Unit Regulatory Affairs, International RA, Supply Chain, Labeling, Marketing, IT/System Administrators, and Quality.

Key Responsibilities

Regulatory & Product Data Management

• Ensure data accuracy, consistency, and traceability to support global registrations, product releases, and lifecycle changes.

• Partner with Regulatory colleagues to maintain regulatory and product data used for submissions to external regulatory databases, including GUDID and EUDAMED.

• Perform routine data entry, validation, reconciliation, tracking, and reporting activities to support audits, inspections, and internal reviews.

• Identify opportunities to improve data quality, efficiency, and regulatory data governance.

Distribution Control & Operational Support

• Support the implementation and ongoing maintenance of new transitional distribution-control processes.

• Coordinate with cross‑functional teams to enable the timely and compliant release of products.

• Monitor data dependencies and identify risks or issues that could impact product availability or regulatory compliance.

Cross-Functional Collaboration

• Partner closely with Master Data Management, Corporate RA, Advanced Patient Monitoring (APM) RA, In-Country RA, Supply Chain, Marketing, Labeling, Quality and IT/System Administration teams to maintain high-quality product data.

• Serve as a knowledgeable resource for regulatory and product data questions related to products or systems.

• Work with global partners and flex working hours when needed to support international collaboration.

Systems, Reporting & Continuous Improvement

• Act as a power user of regulatory and product data systems; provide guidance and support to other system users.

• Provide subject‑matter expertise, data collection support, and submission coordination for system users.

• Collect, analyze, and interpret data to generate reports, metrics, and insights for stakeholders.

• Support ad hoc data requests and data‑driven projects.

• Review existing processes, systems, and documentation to identify and recommend improvement opportunities.

• Contribute to system enhancements, testing, and process improvements.

• Troubleshoot data or system issues, escalate appropriately, and collaborate with IT/system support teams.

Required Qualifications

• Strong attention to detail with excellent analytical, problem‑solving and organizational skills.

• Proficiency in Excel and data manipulation or reporting tools.

• Demonstrated ownership and accountability for assigned work.

• Self‑motivated, proactive, and adaptable with a continuous learning mindset.

• Ability to manage multiple priorities and stakeholders in a fast-paced, regulated environment.

• Results‑driven, diligent, and able to work independently.

• Strong written and verbal communication skills.

Preferred Qualifications

• Bachelor’s degree in a scientific, engineering, or regulatory field (or equivalent experience).

• Minimum of 3 years of experience in regulatory affairs, regulatory operations, data management, or a compliance‑driven environment.

• Demonstrated ability to learn quickly and adapt to new systems, tools and processes.

• Knowledge of EU MDR/MDD, FDA medical device regulations, and other international regulatory frameworks.

• Prior experience with product data management, ERP, or distribution control systems.

• Experience with Master Data Management principles and tools.

• Familiarity with UDI requirements, CE marking, and country‑specific licensing processes.

• Working knowledge of ERP system execution and workflows (e.g., SAP).

• Proven ability to collaborate cross‑functionally in a global, regulated organization.

This role requires independent judgment, regulatory data expertise, and collaboration across functions. The role may provide guidance or informal mentoring to peers but does not include people‑management responsibilities.

This role provides an excellent opportunity for a detail-oriented data steward with strong analytical skills to contribute meaningfully to the success of the Advanced Patient Monitoring business by ensuring the accuracy, integrity, and compliance of critical product and regulatory data.

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Required Skills

Optional Skills

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Primary Work Location

USA CA - Irvine Laguna Canyon

Additional Locations

DOM San Cristobal - Nave 25-Merengue

Work Shift

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information

$80,600.00 - $133,000.00 USD Annual