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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:
The Regulatory Affairs team is helping to ensure speed to market for BD’s creative medical technologies by having an acutely patient-centric mindset.
The Senior International Regulatory Affairs (RA) Specialist will be part of Medication Delivery Solutions (MDS) RA organization. The specialist will support international registrations submissions, project timeline processes and systems designed to ensure that all regulatory requirements are met.
Responsibilities:




The Senior International Regulatory Affairs Specialist will be responsible for partnering in the preparation and approval of regulatory submissions of medical devices worldwide.
Job Responsibilities:
Leads collecting, compiling, and analyzing, country specific regulatory requirements
Drives international registrations according to project plan
Reviews and approves technical documentation to ensure required information and data for regulatory submissions are included.
Prepares and/or compiles information required by international regulatory associates to register or maintain registration of products in international regions.
Collaborates with cross-functional teams for preparation of additional data/information requested by notified body/ regulatory agencies and prepares appropriate responses to all requests.
Navigates, interprets, and applies Design History File (DHF)/Technical File (STED) content to assess regional applicability and support international regulatory submissions.
Develops and executes regulatory strategies for product reg

📌 Sr International Specialist (Bengaluru)
🏢 BD
📍 Bengaluru