Regulatory Affairs Specialist, Ops - Johnson & Johnson MedTech, Circulatory Restoration

Johnson & Johnson seeks a Regulatory Affairs Specialist to support global medical device approvals for cardiovascular solutions. The role involves managing regulatory submissions, documentation, licensing records, and compliance support across multiple geographies.

Responsibilities

• Publish worldwide regulatory submissions according to geography-specific requirements
• Track and manage annual licenses, registrations, and renewal documentation
• Archive submissions and regulatory correspondence in designated repository
• Author and route document changes through electronic control systems
• Support audit activities and provide country-specific regulatory assistance

Requirements

• Bachelor's degree; science, math, engineering, or medical field preferred
• Minimum 2 years regulatory experience in healthcare industry
• Advanced proficiency in MS Word, Excel, SharePoint, Adobe, PowerPoint
• Strong digital aptitude with databases and ability to learn new platforms
• Detail-oriented with excellent organizational and time management skills
• Clear verbal and written communication across organizational levels
• Notary Public Commission or willingness to obtain