Sr. Director, Regulatory Affairs

Biofourmis brings the right care to every person, no matter where they are. The company’s AI-driven solution collects and analyzes patient data in real time and identifies shifts that require proactive interventions. This vital innovation provides people everywhere with connected access to hospital-level services, virtual provider networks for remote care, and life-changing clinical trials—all without leaving their homes. Trusted by leading health systems, payers, biopharma companies and patients alike, Biofourmis’ connected platform improves patient outcomes, prevents hospital readmissions, accelerates drug development, and closes critical gaps in care—ultimately making science smarter, healthcare simpler, and patients healthier. Biofourmis is a global technology company enabling care delivery, with headquarters in Boston and key offices in Singapore and India.

Sr. Director Regulatory Affairs

The Sr. Director Regulatory Affairs will develop and implement the long range regulatory and compliance strategy while leading the regulatory aspects of product development and processes for the Biofourmis remote patient monitoring platforms, pharma partnerships, and DTx algorithms. 

Job Overview:

• Provides guidance and support on administrative and operational activities 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, 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.
• Regularly interacts with company executives, leaders and customers to collaborate and formulate plans to achieve desired outcomes.
• Works on complex challenges that require in depth knowledge of quality and regulatory principles and practices.
• Oversees and ensures proper staff allocation, support and development within departmental budgets.
• Manages direct staff and personal involvement with broad cross functional teams to deliver high quality propositions and solutions in a compliant and efficient manner.
• Ensures all products are released to established procedures and meet required policies, regulations, and customer requirements.

Responsibilities

Reporting to the Sr. VP of Q&R, the Sr Director will have responsibility for;

• Establishing and maintaining product strategy and compliance with a primary focus on the US, North and South America, and EU markets.
• 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 specifications prior to market launch and implementation
• Establishing and overseeing key processes that require timely and effective execution
• Supporting and guiding product development and manufacturing teams to ensure compliance to applicable requirements and regulations.

Requirements

• Typically requires a scientific degree within Engineering, data science, computer science, or other relevant technical discipline with 15 years similar experience in regulated industry, ten years with a Masters, and 7 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.
• 5+ years of management experience
• Direct experience with Software as a Medical Device, IEC 62304 / 82304, Digital Therapeutics, and software development practices a plus
• Knowledge of hardware based device development, compliance testing, and documentation a plus.