Global Regulatory Affairs Lead, Medical Devices

Becton Dickinson; Franklin Lakes (NJ); On-site; USD 110,000 - 176,000; Full time

Benefits offered by this job

Medical coverage

401(k) Plan

Paid time off

Job summary

Becton Dickinson seeks a Senior International Regulatory Affairs Specialist to lead regulatory submissions worldwide for medical devices. You will partner with cross-functional teams and drive registrations in international regions, including strategy and lifecycle changes.

You will interpret DHF/STED content, maintain documentation, and identify regulatory risks with mitigation plans to keep projects on track.

Qualifications

• 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 industry
• Experience with international regulatory product registrations across multiple regions (CASAJ, Greater China, LATAM, Canada, EMEA)
• Working knowledge of STED, technical files, design dossiers, and submission structure
• Digital literacy with regulatory, quality, and business systems/tools (SAP, MasterControl, JDE, Microsoft)

Responsibilities

• Leads collecting, compiling, and analyzing country-specific regulatory requirements.
• Drives international registrations according to project plan.
• Reviews and approves technical documentation for regulatory submissions.
• Prepares information required by regulatory associates to register products internationally.
• Collaborates with cross-functional teams to prepare data requested by authorities and responses.
• Interprets DHF/STED content to support regional regulatory submissions.
• Develops regulatory strategies for product registrations, renewals, and lifecycle changes.
• Identifies regulatory risks and mitigates issues to maintain timelines.
• Uses multiple quality systems to ensure timely registrations.
• Communicates regulatory impact assessments and submission statuses to Supply Chain for continuity.
• Obtains regulatory certificates such as CFGs and FSCs
• Coordinates responses to authority questions with SMEs.
• Supports lifecycle activities like renewals and labeling updates.
• Maintains regulatory documentation and tracking systems.
• Evaluates product changes and regulatory risks for market access.
• Prepares submissions and ensures compliance with regulations.
• Develops submission pathways for global registrations and lifecycle management.

Skills

Regulatory submissions

Global registrations

DHF/STED knowledge

Regulatory strategy

Cross-functional collaboration

Digital literacy

Education

Bachelor's degree in health science or related field

Tools

SAP

MasterControl

JDE

Microsoft Office

Job description

Becton Dickinson seeks a Senior International Regulatory Affairs Specialist to lead regulatory submissions worldwide for medical devices. You will partner with cross-functional teams and drive registrations in international regions, including strategy and lifecycle changes.

You will interpret DHF/STED content, maintain documentation, and identify regulatory risks with mitigation plans to keep projects on track.