Director, Regulatory Affairs

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

• Develop and implement long-range regulatory and compliance strategy • Lead product submissions and regulatory operations • Ensure compliance with regulatory agencies and market requirements • Oversee key processes and guide product development teams • Interact with executives, leaders, and customers for desired outcomes

Requirements

• Scientific degree in relevant technical discipline • 8 years of experience in regulated industry, 5 years with a Masters, and 3 years with a PhD • Experience with Pharma/Biotech product development and Clinical trials • Knowledge of medical device regulations like 21 CFR parts 50, ICH R2, ISO standards, and others • 10+ years in a regulated environment • 5+ years of management experience • Experience with Software as a Medical Device and software development practices

Benefits

• Base salary range from $165,000 to $200,000 • Competitive benefits package • Opportunity to work with cutting-edge technology and a global team