Staff Regulatory Affairs Specialist
MedTechPharmaBiotechRegulatory Affairsheorcroinformaws
Job description


 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 located ONSITE in Franklin Lakes, NJ *** Responsibilities Develop and maintain weekly and monthly globalization and regulatory reporting. Create and manage Power BI dashboards, metrics, and executive-level reporting. Analyze large regulatory, business, and financial datasets to identify trends, risks, and opportunities. Translate regulatory data into actionable business insights that support registration prioritization, resource planning, and market access decisions. Support registration-to-revenue mapping and identify risks impacting business objectives. Participate in governance forums and provide data-driven recommendations to leadership. Facilitate alignment across Regulatory Affairs, Marketing, Finance, and Platform teams. Leverage AI tools, including Microsoft Copilot and automation technologies, to improve reporting, analytics, and operational efficiency. Ensure data accuracy, integrity, and consistency across reporting systems and dashboards. Proactively identify and escalate risks, dependencies, and execution challenges impacting globalization initiatives. Qualifications Required Bachelor's degree in a scientific, technical, business analytics, data management, or related field. Minimum 5 years of experience in analytics, reporting, data management, business intelligence, or related disciplines. Minimum 3 years medtech, pharma, or biotech experience Advanced proficiency in Power BI, Excel, AI-Enabled Reporting & Automation, and Microsoft 365 applications. Experience working with large, complex datasets and translating data into business insights. Strong analytical, communication, and cross-functional collaboration skills. Preferred Minimum 2 years of Regulatory Affairs experience. Knowledge of international medical device regulatory processes and submission lifecycles. Experience supporting globalization, market access, or portfolio management initiatives. Key Competencies Regulatory Analytics & Business Intelligence Power BI Dashboard Development Data Analysis & Visualization AI-Enabled Reporting & Automation Globalization & Market Access Support Portfolio Prioritization Strategic Decision Support Cross-Functional Collaboration Risk Assessment & Escalation 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. Health and Well-being Benefits Medical coverage Health Savings Accounts Flexible Spending Accounts Dental coverage Vision coverage Hospital Care Insurance Critical Illness Insurance Accidental Injury Insurance Life and AD&D insurance Short-term disability coverage Long-term disability insurance Long-term care with life insurance Other Well-being Resources Anxiety management program Wellness incentives Sleep improvement program Diabetes management program Virtual physical therapy Emotional/mental health support programs Weight management programs Gastrointestinal health program Substance use management program Musculoskeletal surgery, cancer treatment, and bariatric surgery benefit Retirement and Financial Well-being BD 401(k) Plan BD Deferred Compensation and Restoration Plan 529 College Savings Plan Financial counseling Baxter Credit Union (BCU) Daily Pay College financial aid and application guidance Life Balance Programs Paid time off (PTO), including all required State leaves Educational assistance/tuition reimbursement MetLife Legal Plan Group auto and home insurance Pet insurance Commuter benefits Discounts on products and services Academic Achievement Scholarship Service Recognition Awards Employer matching donation Workplace accommodations Other Life Balance Programs Adoption assistance Backup day care and eldercare Support for neurodivergent adults, children, and caregivers Caregiving assistance for elderly and special needs individuals Employee Assistance Program (EAP) Paid Parental Leave Support for fertility, birthing, postpartum, and age-related hormonal changes Leave Programs Bereavement leaves Military leave Personal leave Family and Medical Leave (FML) Jury and Witness Duty Leave 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 bui
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