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.
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 registrations, renewals, and lifecycle changes to support business objectives and market access requirements.
- Proactively identifies regulatory risks, assesses potential business impact, develops mitigation plans, and escalates critical issues in a timely manner to enable effective decision-making and maintain project timelines.
- Navigates and works effectively across multiple quality management systems, regulatory processes, and regional requirements to ensur

📌 Sr. International RA Specialist (Bengaluru)
🏢 Becton Dickinson
📍 Bengaluru