Sr. International RA Specialist

Partner in the preparation and approval of regulatory submissions for medical devices worldwide.

Lead the collection, compilation, and analysis of country-specific regulatory requirements.

Drive international product registrations according to project plans.

Review and approve technical documentation to ensure required information and data are included in regulatory submissions.

Prepare and compile information required by international regulatory associates to register or maintain product registrations across international markets.

Collaborate with cross-functional teams to prepare additional data and information requested by notified bodies and regulatory agencies.

Prepare appropriate responses to regulatory authority and notified-body requests.

Navigate, interpret, and apply Design History File (DHF), Technical File, and STED content to assess regional applicability and support international submissions.

Develop and execute regulatory strategies for product registrations, renewals, and lifecycle changes.

Support business objectives and market-access requirements through appropriate regulatory pathways.

Proactively identify regulatory risks and assess their potential business impact.

Develop mitigation plans and escalate critical regulatory issues in a timely manner to support decision-making and protect project timelines.

Work effectively across multiple quality-management systems, regulatory processes, and regional requirements.

Ensure Change Control-related submission tasks are completed.

Compile and communicate worldwide regulatory impact assessments and submission/approval status to Supply Chain to support regulatory compliance and business continuity.

Obtain regulatory certificates including Certificates of Governmental Free Sale (CFGs) and Free Sale Certificates (FSCs).

Generate and coordinate responses to regulatory authority questions and deficiency letters in collaboration with internal subject-matter experts.

Support global product lifecycle activities, including regulatory renewals, labeling updates, and change assessments.

Evaluate product changes and post-market impacts from a regulatory perspective.

Maintain regulatory documentation, records, and tracking systems.

Support international registrations and assessments across regions including CASAJ, Greater China, LATAM, Canada, and EMEA.

Apply regional regulatory requirements to international product-registration activities.

Working knowledge of STED, Technical Files, Design Dossiers, and required regulatory submission structures and content.

Develop regulatory strategies and submission pathways for global registrations and lifecycle-management activities.

Assess regulatory requirements and ensure submissions comply with applicable regulations and standards.

Use regulatory, quality, and business systems/tools including SAP, MasterControl, JDE, and Microsoft tools.

Demonstrate Microsoft Office proficiency, including AI Copilot, Agent, Word, Excel, PowerPoint, and Power BI.

Exercise sound regulatory judgment and manage competing priorities to achieve regulatory objectives.

Identify risks, assess impacts, and provide recommendations supporting business decisions.

Communicate regulatory strategies, issues, and potential impacts to stakeholders and leadership.

Collaborate with regional, cross-functional, and business partners to deliver regulatory outcomes.

Build strong working relationships and contribute to a collaborative team environment.

Coordinate activities proactively to ensure successful execution of deliverables.

Drive continuous improvement in regulatory processes, submission quality, compliance, and operational efficiency.

Expand regulatory knowledge and apply regulatory best practices.

Adapt to feedback and maintain high-quality execution under tight deadlines.

Communicate complex regulatory information clearly to both technical and non-technical audiences.

Deliver concise status updates, presentations, and regulatory recommendations.

Facilitate alignment through effective listening, documentation, and stakeholder engagement.

Bachelor's degree in health science, life science, biology, chemistry, bio-engineering, microbiology, or a 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 global regions.

Primary work location is BD's Bengaluru Technology Campus.

The position is in-office and emphasizes face-to-face collaboration, learning, teamwork, and professional development.

BD promotes a culture focused on learning, growth, collaboration, and healthcare innovation.

BD describes a workplace designed to help employees learn, grow, and thrive.

The company emphasizes in-person collaboration as a means of supporting learning, progress, and stronger team culture.

BD is an Equal Opportunity Employer and states that employment decisions are made without discrimination based on legally protected characteristics.