Sr. RA Operations Analyst

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 Job Summary: Key Responsibilities Identify, submit, and maintain regulatory information in internal and external regulatory databases. Lead STED periodic review activities, including planning, coordination with SMEs, content updates, and ensuring alignment with EU MDR requirements and internal standards. Own and maintain Summary of Safety and Clinical Performance (SSCP) documents, including updates, reviews, and coordination with cross-functional stakeholders to ensure compliance. Prepare and maintain technical documentation (e.g., STED/Technical Files) for CE marking with input from R&D, Quality, Manufacturing, and other functions. Develop, maintain, and enhance Regulatory dashboards and metrics (e.g., Power BI/Excel) to track periodic review status, compliance, and operational performance. Drive data-driven insights by creating and maintaining dashboards that support audit readiness, resource planning, and continuous improvement. Write, update, and continuously improve SOPs, Work Instructions, and process documentation, ensuring alignment with evolving regulatory requirements and internal processes. Coordinate and collect regulatory information from cross-functional teams (R&D, Manufacturing, QA, Medical Affairs, etc.) for documentation updates. Support submissions to external regulatory databases, as required. Coordinate and respond to internal and external requests for product and regulatory information in a timely manner. Qualifications Educational Background: Bachelor's degree Professional Experience: Typically 4 years of Regulatory Affairs experience in the medical device industry, including international registrations, sustaining support, and technical documentation. Experience supporting or leading EU MDR Technical Documentation/STED activities is preferred. Experience with regulatory operations, data management systems (e.g., RIM), and dashboards/analytics tools (e.g., Power BI, Excel) is preferred. Knowledge and Skills Knowledge: Working knowledge of EU MDR (2017/745) and 21 CFR Part 820 (or applicable QMS requirements). Familiarity with regulatory frameworks for global registrations and post-market requirements. Skills: Strong analytical and data-driven mindset with experience in dashboard creation and maintenance. Proficiency in Microsoft Office (Word, Excel, PowerPoint); experience with Power BI or similar tools preferred. Excellent written and verbal communication skills. Strong project management and organizational skills, with the ability to manage multiple priorities. High attention to detail and ability to work independently. Ability to collaborate effectively across global, cross-functional teams. 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? A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates. To learn more about BD visit https://jobs.bd.com/ Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status. PDN #LI-PRO Management Level JG 3 (P2/P3/M1) 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 . Primary Work Location IND Bengaluru - Technology Campus Additional Locations Work Shift BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.