Principal Regulatory Affairs Specialist

Job Summary

A company is looking for a Principal Regulatory Affairs Specialist.

Key Responsibilities

• Provide regulatory guidance to various departments and represent regulatory affairs in project meetings
• Independently prepare and submit regulatory filings, including 510(k)s, and manage interactions with regulatory authorities
• Ensure compliance with regulatory requirements and maintain documentation for design dossiers and technical files

Required Qualifications

• Bachelor's Degree
• A minimum of 4 years working in the medical device industry
• 2-4 years' experience in regulatory affairs required
• Proven ability to prepare and submit FDA documents in a timely manner
• Experience with CE marking of devices through design dossier or technical file process