Senior International Regulatory Affairs Specialist
$110.2k - $176.4kBecton Dickinson & Co
Senior International Regulatory Affairs Specialist at Becton Dickinson responsible for leading medical device regulatory submissions and product registrations across global markets. The role involves managing international approval processes, technical documentation review, cross-functional collaboration, and regulatory strategy development to support market access.
Responsibilities
- Lead collection, compilation, and analysis of country-specific regulatory requirements for device registrations
- Drive international product registrations according to project timelines and business objectives
- Review and approve technical documentation to ensure regulatory submission completeness and accuracy
- Develop regulatory strategies for product registrations, renewals, and lifecycle changes
- Identify regulatory risks, assess business impacts, and escalate critical issues to leadership
Requirements
- Bachelor's degree in health science, life science, biology, chemistry, bio-engineering, microbiology, or related field
- Minimum 6 years medical device industry experience
- International regulatory registration experience across multiple regions (CASAJ, Greater China, LATAM, Canada, EMEA)
- Working knowledge of STED, technical files, design dossiers, and submission structures
- Proficiency with SAP, MasterControl, JDE, and Microsoft Office tools
- Experience navigating Design History Files and reviewing Design Verification reports
Vacancy posted 8 days ago
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