Senior Regulatory Affairs Specialist

Job Summary

Providing regulatory guidance to product development teams, the full-time Senior Regulatory Affairs Specialist II will author US FDA premarket submissions, manage regulatory operations, and collaborate with cross-functional partners to ensure compliance with applicable regulations while working remotely.

Key responsibilities

• Serve as the regulatory representative, offering guidance to product development and sustaining project teams
• Author US FDA premarket submissions and international submissions, collaborating with key staff for timely submissions
• Monitor regulatory landscape changes and author impact assessments for proposed or issued regulatory guidance and legislation

Required qualifications

• Bachelor's degree in Engineering, Science, or a relevant technical discipline
• Minimum of 7 years of Regulatory Affairs experience in a medically regulated environment, with at least 5 years in a medical device company (US FDA Class II)
• Regulatory Affairs Certification (RAC) through Regulatory Affairs Professional Society (RAPS) is preferred