Senior International Regulatory Affairs Specialist Job at Becton Dickinson, Franklin Lakes, NJ

  • Becton Dickinson
  • Franklin Lakes, NJ

Job Description

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

Job Tags

Work at office

Similar Jobs

NielsenIQ

Account Director - MRI-Simmons Agency Vertical Job at NielsenIQ

 ...requires approximately 25% travel, with regular client and in-agency engagement expected. Who We Are MRI-Simmons, a joint venture majority...  ...can also be leveraged across enrichment, activation, advanced advertising, and measurement use cases. About This Job Were looking for a... 

The Patriot Group

Truck Driver & Equipment Operator Job at The Patriot Group

 ...Overview: As a Truck Driver and Equipment Operator within our 3PL utility logistics operation, you play a key role in keeping our customers...  ...) Experience operating dump trucks, tractortrailers, and box trucks Proven experience in logistics, transportation, or 3PL... 

Gene Juarez Salons & Spas

Experienced Hair Stylist Job at Gene Juarez Salons & Spas

 ...more details: At Gene Juarez, we offer more than just a career, we provide an inviting, upscale environment where artistry and personalized service converge. Whether youre beginning your journey or you are a seasoned professional, we create a space for you to refine... 

Barnhart Crane & Rigging

Director of Projects Job at Barnhart Crane & Rigging

 ...Position Summary: The Director of Projects provides leadership, governance, and oversight for Barnhart's project portfolio and project management program across the branch network. This role partners with Branch Managers, Project Managers, Regional Leadership, Senior...