Biofourmis is hiring a
Director, Regulatory Affairs in United States

Summary

The Director of Quality and Regulatory Affairs at Biofourmis leads the development and implementation of regulatory and compliance strategies for the company's remote patient monitoring platforms and pharma partnerships on a global basis. They are responsible for establishing and maintaining product compliance, supporting sales and business development activities, leading product submissions, managing compliance to regulatory requirements, and ensuring consistency and delivery of products and services.

Requirements

• 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
• Experience with Pharma / Biotech product development, Clinical trial management, and associated documentation
• 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, 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

Responsibilities

• Developing and implementing the long range regulatory and compliance strategy
• Leading and directing organizational development, processes and activities required to support Biofourmis remote patient monitoring platforms and pharma partnerships on a global basis
• Establishing and maintaining the product compliance strategy per market requirements
• Supporting customer sales and business development activities (including sales proposals, contracts, and audits) requiring regulatory guidance and oversight
• Leading product submissions, Competent Authority interactions (Q-Subs), and associated regulatory operations and processes
• Managing compliance to the requirements established by applicable Regulatory Agencies (Competent Authorities)
• Ensuring consistency and delivery of product and services within the implemented market requirements
• Managing, reviewing, and approving finished product and service specifications prior to market launch and implementation
• Establishing and overseeing key processes that require timely and effective execution
• Supporting and guiding product development, service, and manufacturing teams to ensure compliance to applicable requirements and regulations

Preferred Qualifications

Experience with Software as a Medical Device, IEC 62304 / 82304, Digital Therapeutics, and software development practices