Senior Regulatory Affairs Specialist

Becton Dickinson Medical Devices•Warwick, RI

16h•Onsite

About The Position

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.

Requirements

Minimum BA/BS required in a technical, scientific, data management, or related discipline.
Minimum 5 years of data management, or related discipline
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, PowerBI, Excel, Copilot, Agents, etc.) (required)
Cross - Functional Communication & Coordination
Able to translate regulatory and data insights into: Clear, nontechnical language and a ctionable 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

Nice To Haves

Minimum 2 years of regulatory affairs experience
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)

Responsibilities

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
Execute monthly dashboard refreshes using multiple regulatory data sources
Use dashboards to drive alignment and informed decision - making
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
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
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