Regulatory Affairs Manager / ...

About the role

The Regulatory Affairs Manager ensures compliance to FDA and other applicable regulations. In this role, you will lead the preparation, analysis, and submissions of dossiers to various governing agencies in supporting business growth.

Responsibilities

• Lead the preparation, analysis, and submissions of dossiers to various governing agencies in support of business growth.
• Support compliance with applicable regulations including ISO, local, state, and/or federal requirements.
• Prepare international regulatory submissions and FDA submissions which may include device 510(k), IDEs, PMAs).
• Serve as the regulatory representative on selected project teams.
• Develop departmental SOPs/policies regarding regulatory matters.

Qualifications

• Bachelor's degree required. Scientific or engineering field preferred.
• 5+ years of medical device regulatory affairs experience.
• Must have authored 510(k) submissions.
• Must have knowledge of U.S. FDA regulations and standards.
• 3+ years of experience interacting with FDA and/or other regulatory agencies.
• Experience with devices containing software is strongly preferred.
• Solid understanding of manufacturing and change control, and an awareness of regulatory trends.