Director of Quality Assurance

April 20

Biofourmis

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As a global leader in digital therapeutics, we combine the power of AI with wearables data to enable personalized care.

Physiology Science • Post-acute Monitoring • Physiology Monitoring • Artificial Intelligence • Digital Health

201 - 500

Description

• Responsible for developing and implementing the long-range regulatory compliance strategy • Lead and direct organizational development, processes, and activities to support the Biofourmis business strategy • Report to the Sr. VP of Q&R • Establish and maintain a product compliance strategy for products in various markets such as the US, EU, and Asian markets • Ensure consistency and delivery of product and services within the implemented market requirements • Analyze and support root cause analysis and drive continuous improvement • Guide teams on computer system validation and assurance • And more

Requirements

• Typically requires 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 and ICH R2 (GCPs), 803, 806, 812, and 820, ISO 13485, ISO 14971, IEC 62366, IEC 62304, EU MDR, Canadian MDR, and ANVISA • 10+ years in a regulated environment such as medical device, pharmaceutical, or other relevant fields • 5+ years of management experience • Experience with Software as a Medical Device, IEC 62304 / 82304, Digital Therapeutics, and software development practices a plus • Experience with Biotech product development, Clinical trial management, and associated documentation a plus

Benefits

• Base salary range of $165,000 to $200,000 based upon experience • Other benefits not specified in the job opening