Biofourmis is hiring a
Senior Regulatory Affairs Specialist in United States

Summary

The Senior Regulatory Affairs Specialist will support the regulatory strategy of Biofourmis' pharma partnerships and DTx algorithms, ensuring compliance with applicable Regulatory Agencies. The role requires a scientific degree, 8 years of experience in regulated industry, and knowledge of global medical device regulations.

Requirements

• A scientific degree within Engineering, data science, computer science, or other relevant technical discipline with 8 years similar experience in regulated industry, 5 years with a Masters, and 3 years with a PhD
• Working knowledge of appropriate global medical device regulations, requirements, and standards such as 21 CFR parts 50 (GCPs), 803, 806, 812, and 820, ISO 13485, 14971, ICH E6, EU MDR, Canadian MDR, and ANVISA
• 10+ years experience in regulated medical devices and / or pharmaceuticals developing, conducting, and executing clinical and regulatory strategy and submissions
• Direct experience with Software as a Medical Device, IEC 62304 / 82304, Digital Therapeutics, and software development practices

Responsibilities

• Supporting and maintaining the pharma partnership product strategies and deliverables within the assigned project teams
• Managing compliance to the requirements established by applicable Regulatory Agencies (Competent Authorities) throughout the assigned projects
• Ensuring consistency and delivery of product and services within the implemented market requirements
• Managing, reviewing, and approving finished product specifications prior to market launch and implementation
• Providing guidance to product development and manufacturing teams to ensure compliance to applicable requirements and regulations

Benefits

Base salary range for this position is $90,000 to $130,000 based upon experience