VP of Regulatory and Quality (Remote)

Company Description

Founded in 2013, Tidepool is a 501(c)3 nonprofit organization dedicated to making diabetes data more accessible, actionable, and meaningful for people with diabetes, their care teams, and researchers. The 510(k)-exempt Tidepool Data Platform allows people with diabetes to see all of their data in one place. Tidepool+ adds enterprise population health features for healthcare providers. Tidepool Loop is an FDA-cleared automated insulin delivery app,  intended to work with commercially available interoperable insulin pumps and CGMs. (Tidepool Loop is not currently available for use.)

Job Description

We are seeking an experienced and strategic leader to join our executive team as the VP of Regulatory and Quality. This role is crucial in ensuring our software as a medical device (SaMD) products meet the highest quality standards and comply with global regulatory requirements. The ideal candidate will have a proven track record in navigating complex regulatory landscapes, implementing robust quality management systems, and driving regulatory strategy and quality system compliance in an agile software development environment. While the regulatory team may grow over time, this is a hands-on role - you’ll be directly involved in creating Tidepool’s regulatory documents and managing Tidepool’s regulatory and quality processes. This role reports to Howard Look, CEO. 

Due to the changing needs of this role, Tidepool is amenable to structuring the role to benefit both the chosen candidate and Tidepool. This may include full-time exempt, fractional, or other. This role is remote.

Essential Duties and Responsibilities

• Develop and execute the overall regulatory and quality strategy for the company's SaMD products
• Lead the regulatory affairs and quality systems efforts, fostering a culture of quality and compliance
• Ensure compliance with FDA regulations, CE Marking requirements under EU MDR, and other international regulatory schemes(e.g., MDSAP)
• Oversee the implementation, maintenance, and use of Tidepool’s Quality Management System (QMS)
• Adapt quality and regulatory processes to support agile software development methodologies
• Manage relationships with regulatory authorities (e.g., FDA, MDSAP participants, EU Notified Bodies), and represent the company in regulatory discussions
• Guide product development teams on regulatory and quality system requirements
• Oversee FDA and international regulatory submissions and approvals for new products and product changes
• Oversee regulatory and quality system inspections/audits
• Develop and maintain standard operating procedures and training materials
• Stay current with evolving regulations and industry best practices, particularly in SaMD
• Collaborate with cross-functional teams to integrate quality and regulatory considerations into product development cycles
• Provide executive leadership with strategic advice on quality and regulatory matters
• Represent Tidepool in regulatory and industry working groups and public forums
• Inform clinical development plan to achieve successful regulatory authorization in target markets
• Coordinate regulatory strategy with selected partners for integrated diabetes management systems
• Author submissions and technical documentation to achieve SaMD authorizations in desired markets
• Develop systems to monitor product and facility submissions, certifications, renewals, and registrations
• Enhance design control processes to facilitate improvements in development, design transfer, and product release while maintaining compliance with applicable regulations/standards

Qualifications

• Bachelor's degree in a relevant field; advanced degree is a plus
• 5+ years of experience in global quality systems and regulatory affairs for medical devices
• Extensive knowledge of FDA and international regulations for medical devices, especially those specific to SaMD
• In-depth understanding of CE Marking requirements under EU MDR, and experience with MDSAP. Other international product registration experience is a plus.
• Proven experience implementing and maintaining Quality Management Systems for medical device companies
• Strong familiarity with agile software development methodologies and their application in a regulated environment
• Knowledge of AAMI TIR-45 and experience applying its principles to SaMD development. Experience with IEC 62304 is a plus.
• Experience with quality system and risk management processes and standards (e.g., ISO 13485 and ISO 14971)