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 strategic, hands-on Regulatory Affairs Senior Manager to lead and execute global product data governance, distribution control, and regulatory data compliance activities.

This role balances day‑to‑day operational execution with leadership accountability in a highly collaborative team environment.

This role provides leadership, strategic direction, and direct execution support for regulatory and product data operations, ensuring scalable, compliant solutions that support business growth, operational excellence, and regulatory readiness.

Role Overview

This role is accountable for defining, leading, and personally executing global regulatory and product data strategies, including hands-on management of product attributes, certifications, and country‑specific compliance requirements across regulatory information management, distribution control, and master data systems.

You will ensure sustained compliance with global regulatory requirements and that accurate, validated data supports global commercialization activities, including submissions to regulatory databases such as GUDID and EUDAMED, and other country‑specific regulatory databases.

This role operates with a high degree of autonomy and accountability, combining senior-level decision making with hands-on operational contribution to support efficient, compliant, and scalable business operations supporting global distribution.

Key Responsibilities

Regulatory & Product Data Management

• Establish, maintain, and execute global regulatory and product data governance frameworks, ensuring data accuracy, consistency, traceability, and inspection readiness across product registrations and lifecycle activities.

• Provide senior‑level regulatory leadership while directly managing and updating regulatory and product data used in global submissions, including GUDID, EUDAMED, and other regulatory databases.

• Perform and review data validation, reconciliation, tracking, and reporting activities for product portfolio, audits, inspections, and critical milestones.

• Identify and drive continuous improvement initiatives focused on data quality, process efficiency, system usability, and regulatory risk reduction, partnering with cross‑functional stakeholders as needed.

Distribution Control & Operational Support

• Lead and actively support the design, implementation, and day‑to‑day operation of global distribution control and transitional strategies.

• Coordinate closely with cross‑functional partners to enable timely and compliant product releases, resolving data or process issues through direct involvement when required.

• Proactively assess, investigate, and resolve regulatory data, system, or process risks, escalating issues appropriately while remaining directly engaged in mitigation activities.

Cross-Functional Collaboration & Leadership

• Serve as a senior regulatory business partner and hands‑on contributor, working closely with Master Data Management, Corporate RA, Advanced Patient Monitoring (APM) Business Unit RA, In-Country RA, Supply Chain, Marketing, Labeling, Quality and IT/System Administration teams.

• Act as a recognized subject matter expert, escalation point, and working resource for regulatory and product data strategy, compliance interpretation, and system utilization.

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

• Provide day‑to‑day leadership, mentoring, and workload support, including task prioritization, coaching, and hands‑on assistance.

Systems, Reporting & Continuous Improvement

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

• Ensure consistent and compliant Regulatory system use.

• Define and generate KPIs, dashboards, and reports, performing data extraction, analysis, and interpretation to inform leadership and operational decision‑making.

• Lead and execute complex, high‑impact data initiatives, balancing strategic priorities with tactical execution.

• Champion continuous process/system improvement, digital transformation, and inspection readiness efforts through both leadership and direct contribution.

• Develop, maintain, and manage regulatory and product data process documentation, including SOPs, work instructions, job aids, and system guidance; ensure documentation remains current and aligned with evolving regulatory requirements and business processes.

• Troubleshoot data and system issues directly, partner with IT, and drive issues to resolution, while ensuring business continuity.

Required Qualifications

• Proven ability to lead complex regulatory initiatives while performing detailed, hands‑on regulatory and data management work.

• Strong leadership, influence, and execution skills with the ability to shift seamlessly between strategy and tactical execution.

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

• Proficiency in Excel and data manipulation or reporting tools.

• Strong written and verbal communication skills.

Preferred Qualifications

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

• Minimum of 8 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, including working knowledge of ERP execution and workflows (e.g., SAP).

• Experience with Master Data Management principles and tools.

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

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

This role requires senior-level judgment, regulatory data expertise, and a “player-coach” leadership style. This role provides an opportunity for an experienced regulatory professional to shape global regulatory data strategy while personally ensuring the accuracy, quality, and compliance of critical regulatory and product data. The Senior Manager role may include direct or indirect people management responsibilities and is expected to remain actively engaged in day‑to‑day regulatory and product data execution due to the size and complexity of the team.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

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

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

$164,600.00 - $263,400.00 USD Annual