Explore an Expert Regulatory Affairs role at n!Biomachines, focusing on quality management and regulatory submissions that bring innovative biomanufacturing technologies to market. Join a talented team in the AI sector.
In this individual-contributor position, you will author regulatory submissions to entities like the FDA, ensuring all documentation meets the highest standards. You'll also maintain the quality management system and stay updated on regulatory changes in AI and hardware/software integration.
Key Responsibilities:
• Author regulatory submissions to FDA and EMA agencies
• Develop quality management documentation for products
• Perform gap analyses relative to regulatory standards
• Prepare comprehensive risk management documentation
• Collaborate with regulatory agencies and consultants
Requirements:
• Significant hands-on experience with regulatory submissions
• Robust knowledge of ISO 13485 and GxP
• Proven capability to work independently
• Flexibility for full time, fractional, or advisory arrangements
Become a key player in advancing regulatory strategies at n!Biomachines and drive quality in creative biomanufacturing.
J-18808-Ljbffr

📌 Expert Regulatory Affairs Role In Ai Biomanufacturing Burlington
🏢 n!Biomachines
📍 Burlington