Senior Regulatory Affairs Specialist

Johnson & Johnson seeks a Senior Regulatory Affairs Specialist to coordinate and submit medical device applications to regulatory authorities for orthopaedic products. The role involves managing regulatory submissions, monitoring compliance, and providing strategic input across the product lifecycle.

Responsibilities

• Compile, prepare, review, and submit regulatory applications to authorities
• Monitor and respond to regulatory reports and requests for information
• Review change requests and determine submission requirements
• Develop and maintain regulatory strategies aligned with product lifecycle
• Interface with product development teams to gather information for submissions

Requirements

• Scientific and technical understanding of regulated medical devices
• Experience preparing and submitting regulatory applications to authorities
• Knowledge of medical device classification and regulatory pathways
• Ability to review and approve regulatory submissions and product labeling
• Proficiency in regulatory database management and documentation
• Strong communication skills with internal and external stakeholders