The Senior Regulatory Affairs Specialist will support and carry out the regulatory strategy and other regulatory aspects of product development and processes for the Biofourmis pharma partnerships and DTx algorithms. 

Reporting to the SVP of Q&R, the Senior Regulatory Affairs Specialist will have responsibility for;

• 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
• Supporting key processes that require timely and effective execution
• Providing guidance to product development and manufacturing teams to ensure compliance to applicable requirements and regulations

Job Overview: 

• Provides guidance and support on key product and project deliverables to ensure the effective achievement of business objectives with full regulatory compliance
• Has broad expertise and unique domain knowledge in the areas of clinical research, clinical investigation, pharma development, medical device product development, manufacturing, regulatory submissions, and quality management in the applicable markets
• Has the necessary technical, educational, and work experience (in both medical devices and pharmaceuticals) to become highly knowledgeable with the organizations products.
• Leads and generates product submissions and technical documentation within defined markets such as US under FDA, EU under MDR, and supports international registrations as needed
• Works on complex challenges that require in depth knowledge of quality and regulatory principles and practices
• Ensures all products are released to established procedures and meet required policies, regulations, and customer requirements

Minimum 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 (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
• Knowledge of pharmaceutical development, sensor based Digital Health Technologies, and hardware based device development, compliance testing, and documentation desired.

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