Senior Regulatory Affairs Specialist - Operations
Onsite, Warwick, RI
- 求人ID
- R-542719
- Category
- Regulatory Affairs
- Location
- ウォリック, ロードアイランド州
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
This role is responsible for globalization support and project coordination that enable accurate interpretation of regulatory data, cross functional alignment, and prioritization of international submissions to ensure alignment with MDS business goals.
The role combines operational execution with applied regulatory knowledge to translate complex registration, approval, and financial data into clear, decision-ready insights for cross functional partners (RA, Marketing, Finance, and Platform teams). In addition, the role leads project coordination activities by tracking dependencies, identifying risks, escalating issues, and facilitating alignment between the Regulatory CoE and Platform teams.
Primary Responsibilities:
Weekly Regulatory & Globalization Reporting
• Pull, compile, and distribute weekly MoHapproved andglobalization relevantregistration 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 misalignmentsimpactingtimelines or business expectations
Monthly Global MDS DashboardCreation &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 typesand approval timing implications
• Translate regulatory data into businessrelevant 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 registrationtorevenue mapping based on country approvals, renewals, and market access timing
•Identifyand escalatefinancial expectationsinconsistenciesbetweenprojected revenue vs past performance
Cross-Functional Governance, Project Coordination & Alignment
•Participatein governance forums as a regulatory data interpreterto connect data to decisions
• Track issues, dependencies, and decision points;risks and bottlenecks
•Facilitatealignment between Regulatory CoE and Platform teams
•ProactivelyEscalate 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, PowerBI, 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 reliablewith fixed weekly and monthly reporting cadences
Maintainsdata accuracy and quality under repetitive execution
Proactively escalates risks, misalignment, and execution gaps
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 NJ - Franklin LakesAdditional 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
$106,600.00 - $175,900.00 USD Annual
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