Senior Regulatory Affairs Specialist

A growing medical device company is seeking a Senior Regulatory Affairs Specialist to support global regulatory strategy and submissions across a diverse product portfolio. This role will partner cross-functionally with quality, clinical, and product development teams to ensure compliance with applicable regulations throughout the product lifecycle.

Key Responsibilities

• Support development and execution of regulatory strategies for new and existing products
• Prepare, review, and submit regulatory filings (e.g., 510(k), EU Technical Documentation, and other global submissions)
• Interface with regulatory agencies and notified bodies as needed
• Ensure compliance with FDA, EU MDR, and other applicable global regulations
• Provide regulatory input to cross-functional teams during product development and change management activities
• Support labeling, claims, and promotional review processes
• Maintain regulatory documentation and contribute to internal audits and inspections

Qualifications

• Bachelor's degree in a scientific, engineering, or related field
• 5+ years of experience in Regulatory Affairs within the medical device industry
• Working knowledge of U.S. and international regulatory requirements
• Experience supporting submissions and interacting with regulatory agencies is preferred
• Strong communication and cross-functional collaboration skills

Additional Information

• Exposure to a range of product types and regulatory pathways is beneficial
• Ability to manage multiple projects in a fast-paced environment
• Advanced degree or RAC certification is a plus

This is an opportunity to contribute to a dynamic team supporting innovative medical technologies while maintaining a broad scope of regulatory responsibility.