Regulatory Affairs Manager / Regulatory Affairs Specialist role

Collabera • Mansfield, MA

12d

About The Position

The Regulatory Affairs Manager ensures compliance to FDA and other applicable regulations. In this role, you will lead the preparation, analysis, and submissions dossiers to various governing agencies in supporting business growth. The RA Manager supports compliance with applicable regulations including ISO, local, state, and/or federal requirements. Preparing international regulatory submissions and FDA submissions which may include device 510(k), IDEs, PMAs) and serving as regulatory representative on selected project teams; developing departmental SOPs/policies regarding regulatory matters.

Requirements

• 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

Nice To Haves

• Experience with devices containing software is strongly preferred.
• Solid understanding of manufacturing and change control, and an awareness of regulatory trends

Responsibilities

• Ensures compliance to FDA and other applicable regulations
• Lead the preparation, analysis, and submissions dossiers to various governing agencies in supporting business growth
• Supports compliance with applicable regulations including ISO, local, state, and/or federal requirements
• Preparing international regulatory submissions and FDA submissions which may include device 510(k), IDEs, PMAs)
• Serving as regulatory representative on selected project teams
• Developing departmental SOPs/policies regarding regulatory matters

What This Job Offers

• Career Level: Manager