Senior Regulatory Affairs Specialist

Overview

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 takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of Med Tech 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.

• Weekly Regulatory & Globalization Reporting
  • Pull, compile, and distribute weekly MoH approved and globalization relevant registration reports
  • Interpret approval status, submission stage, and regional context to explain implications for launch timing, renewals, and market access
  • Communicate insights clearly to RA leadership and cross-functional stakeholders
  • Support prioritization
  • Escalate risks or misalignments impacting timelines or business expectations
• Monthly Global MDS Dashboard Creation & Maintenance
  • Execute monthly dashboard refreshes using multiple regulatory data sources
  • Use dashboards to drive alignment and informed decision-making
• Globalization & Regulatory Data Interpretation
  • Interpret submission types and approval timing implications
  • Translate regulatory data into business relevant insights for Marketing, Platform, and Finance
  • Support alignment across CoE and Platform teams on priorities and sequencing
• Key expectation:
  Explains regulatory meaning and execution implications, not just data fields.
• Revenue & Financial Data Mapping
  • Support registration to revenue mapping based on country approvals, renewals, and market access timing
  • Identify and escalate financial expectations inconsistencies between projected revenue vs past performance
• Cross-Functional Governance, Project Coordination & Alignment
  • Participate in governance forums as a regulatory data interpreter to connect data to decisions
  • Track issues, dependencies, and decision points; risks and bottlenecks
  • Facilitate alignment between Regulatory CoE and Platform teams
  • Proactively escalate misalignments to support predictable execution
• Education And Experience
  • Minimum BA/BS required in a technical, scientific, data management, or related discipline.
  • Minimum 5 years of data management, or related discipline
  • Preferred minimum 2 years of regulatory affairs experience
• Knowledge And Skills
  • Advanced Power BI, Excel skills, including lookups, pivots, data comparison, and structured analysis (required)
  • Experience working with large, imperfect, and manually maintained regulatory datasets (required)
  • Strong data validation, reconciliation, and quality control mindset (required)
  • Ability to analyze trends, identify inconsistencies, and support data driven decision making (required)
  • Microsoft Office 365 (Word, Power
    
    BI, Excel, Copilot, Agents, etc.) (required)
  • Working knowledge of:
    International medical device Submissions lifecycle (Preferred)
  • Ability to understand and explain:
    Impact of regulatory status on market access, execution timing, and revenue assumptions (Preferred)
• Cross-Functional Communication & Coordination
  • Able to translate regulatory and data insights into:
    Clear, nontechnical language and actionable prioritization and execution guidance
  • Comfortable influencing alignment without direct authority
  • Able to escalate risks constructively and diplomatically
• Operational Excellence
  • Highly reliable with fixed weekly and monthly reporting cadences
  • Maintains data accuracy and quality under repetitive execution
  • Proactively escalates risks, misalignment, and execution gaps

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…