Regulatory Affairs Specialist

Job Summary

A company is looking for a Regulatory Affairs Specialist - Shockwave.

Key Responsibilities

• Compile, prepare, review, and submit regulatory submissions to authorities outside the US and EU
• Assist with the preparation of product registration documents and maintain regulatory shipping authorization documentation
• Review R&D, quality, preclinical, and clinical documentation for submission filing and ensure compliance with applicable standards

Required Qualifications

• Bachelor's degree and a minimum of 2 years of related experience, or an advanced degree without experience, or equivalent work experience
• Ability to work collaboratively in a fast-paced environment while managing multiple priorities
• Working knowledge of applicable domestic and international regulatory guidelines, policies, and regulations