Senior Regulatory Specialist - Remote

Overview

The Senior Regulatory Specialist is responsible for identifying and organizing regulatory information, monitoring the regulatory environment, and assisting in the preparation of regulatory submissions and communications.

In Short

• Identifies information sources for local, regional, and global regulations.
• Maintains files on regulatory intelligence and relevant information.
• Monitors the regulatory environment by product types and geography.
• Researches requirements for regulatory submissions and compliance activities.
• Assists in the development of regulatory procedures and SOPs.
• Compiles materials for pre-submission reports and communications.
• Tracks the status of applications under regulatory review.
• Communicates with regulators and stakeholders.
• Assists in scheduling meetings with internal stakeholders and regulators.
• Creates clarity and direction amid complexity.

Requirements

• BS in Engineering, Science, or related degree; or MS in Regulatory Science.
• 4+ years of experience in regulatory roles.
• Strong time management and writing skills.
• Ability to convey information clearly to peers and stakeholders.
• Experience in preparing for meetings with regulatory agencies.
• Proficient in composing communications with regulators.
• Ability to develop solutions for complex issues.
• Strong coordination and execution skills.

Benefits

• Opportunity to work with one of the world’s leading medical technology companies.
• Innovative products and services that improve healthcare outcomes.
• Recognition as one of the World’s Best Workplaces.
• Flexible work arrangements.
• Collaborative and supportive work environment.