Overview
Sr International Regulatory Affairs Specialist (Senior International RA) in BD’s Medication Delivery Solutions (MDS) RA organization, supporting international regulatory registrations for medical devices.
What you'll do
- Partner in preparation and approval of international regulatory submissions for medical devices.
- Collect, compile, and analyze country-specific regulatory requirements.
- Drive international registrations according to project plans.
- Review and approve technical documentation for regulatory submission content.
- Navigate and apply DHF/STED content to assess regional applicability.
- Develop regulatory strategies for registrations, renewals, and lifecycle changes.
- Identify regulatory risks, assess impact, develop mitigation plans, and escalate critical issues.
What you'll need
- Bachelor’s degree in health science/life science/biology/chemistry/bio-engineering/microbiology or related field.
- Minimum 6 years of experience in the medical device, diagnostic, biologic, and/or pharmaceutical industry, preferably in regulatory affairs.
- Experience with international regulatory product registrations and assessments across multiple regions (CASAJ, Greater China, LATAM, Canada, EMEA).
- Working knowledge of STED, technical files, design dossiers, and required submission structure/content.
- Digital literacy with regulatory/quality/business systems and tools such as SAP, MasterControl, JDE, and Microsoft tools.
Details
- Primary work location: IND Bengaluru - Technology Campus.
Read the full description and apply on the company’s own careers page.
