Remote Director, Regulatory Affairs

Summary

Join our team - we are Committed, Collaborative and Curious….we are Biofourmis! The Director of Quality and Regulatory Affairs will be responsible for developing and implementing the long range regulatory and compliance strategy by leading and directing the organizational development, processes and activities required to support the Biofourmis remote patient monitoring platforms and pharma partnerships on a global basis.

Requirements

• Typically requires a scientific degree within engineering, data science, computer science, or other relevant technical discipline
• 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

• 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

Benefits

Base salary range for this position is $165,000 to $200,000 based upon experience