Director, Regulatory Affairs

The Director of Quality and Regulatory Affairs is 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. Reporting to the Sr. VP of Q&R, the Director will have responsibility for the following aspects of customer based solutions;

• 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.

Job Overview:

• Ensures all products are released to established procedures and meet required policies, regulations, and customer requirements.
• Provides guidance and support on administrative and operational activities to ensure the effective achievement of business objectives with full quality and regulatory compliance
• Has broad expertise and unique domain knowledge in the areas of pharmaceutical, software, and hardware development, clinical trials systems and processes, manufacturing / distribution, regulatory submissions, and quality management.
• Has the necessary technical, educational, and work experience to become highly knowledgeable with the organizations products and services.
• 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.

Minimum Requirements

• Typically requires a scientific degr...