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
- 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)
- Strong leadership and team management skills
- Excellent communication skills, both written and verbal
- Ability to influence and collaborate effectively with cross-functional teams and executive leadership
- Strategic thinker with a track record of driving regulatory approvals and maintaining compliance
- Experience with diabetes management devices or similar chronic disease management technologies is a plus
Key Competencies
- Regulatory strategy development and execution
- Quality management system implementation and oversight
- Risk management and mitigation
- Agile methodology adaptation for regulated environments
- Cross-functional leadership and collaboration
- Continuous improvement mindset
- Adaptability to evolving regulatory landscapes
- Strategic planning and execution
Compensation: The compensation range for this role is $170,000 - $250,000. To learn more about Tidepool's compensation philosophy please see Tidepool's Employee Handbook.
Time Zones and Locations: You can work from anywhere within the United States. Occasional early mornings and evenings may be requested due to the need for overlapping business hours.
Our Benefits package for full-time employees includes:
- Excellent Medical, Dental, and Vision health insurance
- Health and Dependent Care FSA with a dollar-for-dollar match up to the IRS limit
- Flexible PTO with a recommended minimum of at least three weeks per year
- Eight weeks of paid new parent leave
- A flexible work schedule
- Wellness and Productivity Stipend
- Continuing Education Reimbursement that encourages team members to spend time on professional development
Other Information
At Tidepool, personal experience with diabetes is valued and not required. We seek team members who are empathetic towards chronic conditions and eager to learn about the diabetes experience. For more insights into our work culture, including our commitment to inclusion and diversity, please refer to this blog post about working at Tidepool.
Tidepool is an Equal Opportunity Employer. The company supports diversity and inclusion in its core values and does not discriminate against qualified employees or applicants because of race, color, religion, gender identity, sex, sexual preference, sexual identity, pregnancy, national origin, ancestry, citizenship, age, marital status, physical disability, mental disability, medical condition, military status, or any other characteristic protected by U.S. federal or state law or local ordinance. When necessary, the company will reasonably accommodate employees and applicants with disabilities if the person is otherwise qualified to safely perform all of the essential functions of the position.
