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

Baylor College of Medicine

Physical Medicine & Rehabilitation (Instructor) Job at Baylor College of Medicine

 ...Summary Baylor College of Medicine (BCM) is hiring a Prosthetist/Orthotist for an open position in our Houston Medical Office. The office is a lean digital first office that is part of a joint relationship between Baylor College of Medicine and Ottobock Patient Care... 

ARC Health Partners

Psychiatrist (MD/DO) Job at ARC Health Partners

 ...Psychiatrist (MD/DO) Compensation: 60% of Net Collections; (Estimated earning potential of $210-$270 per clinical session) Employment...  ...Durham office Role Summary North Carolina Mental Health & Psychiatry Group, which partners with and operates out of the Lepage... 

Outlaw Trucking Group

Independent CDL Recruiter | Work From Home | Commission-Based Opportunity Job at Outlaw Trucking Group

 ...is based on your results? We're seeking motivated independent recruiters to help place CDL drivers with trucking companies nationwide....  ...qualified candidates Qualifications Self-starter who enjoys working independently Strong communication and interpersonal... 

Planet Fitness

Overnight Closer Job at Planet Fitness

Benefits: ~401(k)~ Dental insurance ~ Employee discounts ~ Health insurance Job Summary The Overnight Closer (Member Services Representative) will be responsible for creating a positive member experience by providing a superior level of customer service...

The Building Group

COMMUNITY ASSOCIATION MANAGER | PREMIER GOLD COAST CONDOMINIUM | SINGLE-SITE Job at The Building Group

 ...COMMUNITY ASSOCIATION MANAGER | PREMIER GOLD COAST CONDOMINIUM | SINGLE-SITE $95,000+ annually, commensurate with experience The Opportunity The Building Group is seeking an experienced, licensed Community Association Manager to lead the onsite management of...