PHARMAFull-time
Sr. International RA Specialist
By Admin · Regulatory Affairs
BANGALORE (IN)ONSITEPOSTED: 9/13/2026
PHARMAFull-time
HIRING ORGANIZATIONBDMedical Technology / Life Sciences
ROLE OVERVIEW
Senior Regulatory Affairs professional responsible for supporting global medical device registrations and lifecycle activities across multiple international markets. The role combines regulatory strategy, technical documentation review, risk assessment, and cross-functional coordination to enable compliant market access.
ROLE DEFINITION & RESPONSIBILITIES
- •Lead collection, compilation, and analysis of country-specific regulatory requirements
- •Drive international product registrations according to project plans
- •Review and approve technical documentation for regulatory submissions
- •Coordinate responses to notified bodies and regulatory authorities with cross-functional subject matter experts
- •Develop and execute regulatory strategies for registrations, renewals, and lifecycle changes
- •Assess regulatory risks and develop mitigation plans
- •Complete change-control regulatory tasks and communicate worldwide submission and approval status
- •Obtain regulatory certificates such as CFGs and FSCs
Reporting Hierarchy: Reports to a Regulatory Affairs leadership function; Cross-functional collaboration with regional regulatory associates, quality, supply chain, technical subject matter experts, and business stakeholders
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Bachelor's degree in health science, life science, biology, chemistry, bio-engineering, microbiology, or related field
- Minimum 6 years of experience in medical devices, diagnostics, biologics, and/or pharmaceutical industry
- Experience with international regulatory product registrations across multiple regions
- Working knowledge of STED, technical files, design dossiers, and submission structures
- Digital literacy with SAP, MasterControl, JDE, Microsoft Office, AI Copilot, Agent, Word, Excel, PowerPoint, and Power BI
PREFERRED QUALIFICATIONS
- •Experience with regulatory submissions across CASAJ, Greater China, LATAM, Canada, and EMEA
- •Experience with medical device lifecycle management and change assessments
- •Strong regulatory strategy and risk-management experience
- •Experience coordinating multinational cross-functional regulatory programs
REQUIRED VERIFIED SKILLS
International Regulatory Affairs
Medical Device Regulatory Affairs
Regulatory Submissions
STED
Technical Files
Design Dossiers
DHF
Change Control
Regulatory Strategy
Lifecycle Management
Risk Assessment
CFG
FSC
SAP
MasterControl
JDE
Microsoft Office
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Standard corporate benefits, health and wellness programs, paid leave, retirement benefits, and professional development opportunities.
The posting does not disclose a salary range or bonus/equity package. Compensation should therefore be confirmed directly through the employer and evaluated against Bengaluru medical-device regulatory roles requiring 6+ years of experience.
ORGANIZATION CONTEXT & CULTURE
BD is a global medical technology company focused on advancing the world of health through medical technology, devices, diagnostics, and related healthcare solutions.
TEAM SIZE: 70,000+ employees
INDUSTRY: Medical Technology / Life Sciences
Culture: BD emphasizes purpose-driven healthcare innovation, collaboration, continuous improvement, and face-to-face teamwork. The role requires clear communication, decisive leadership, stakeholder engagement, and adaptability across global regulatory environments.
EXPECTED CAREER ROADMAP
Progression can lead toward Regulatory Affairs Manager, Senior Manager, Global Regulatory Strategy, regional regulatory leadership, or broader medical-device regulatory program management roles. Experience across multiple international markets can support advancement into global regulatory leadership positions.
APPLICATION ADVISORY
Highlight 6+ years of regulatory experience and international medical-device registrations; demonstrate knowledge of STED, technical files, DHF, design dossiers, and lifecycle management; quantify successful registrations or approvals across regions; emphasize regulatory strategy, risk assessment, change control, and authority-response experience; showcase SAP, MasterControl, JDE, and Microsoft tools where applicable.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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