Director, Regulatory Affairs

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resources each year. Our team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology.

Are you ready to change the future of kidney stone treatment? We are seeking high achievers who want to be part of a dynamic team working in a fun, diverse atmosphere.

Summary:

We are seeking a strategic and experienced Director,Regulatory Affairsto lead and scale our regulatory function as we grow. This is a high-impact leadership role at a pivotal stage in our company's growth, responsible for shaping and driving regulatory strategy across the business. The ideal candidate brings deep FDA expertise, a strong command of global regulatory landscapes, and a proactive, collaborative mindset to navigating complex, evolving regulatory environments. As a member of the Calyxo Leadership Team, you'll work closely with Research & Development, Quality, Clinical and Medical Affairs, Marketing, and Legal to ensure regulatory alignment from concept through commercialization-balancing speed with compliance as we bring category-defining medical devices to market.

In This Role, You Will:

• Set the global regulatory vision and strategy, ensuring alignment with company goals, development timelines, and market expansion plans.

• Serve as the internal regulatory authority-advising executive leadership and cross-functional stakeholders on risk, opportunity, and regulatory positioning.

• Lead the preparation, submission, and negotiation of U.S. and international regulatory filings (including 510(k)s, letters to file, PMAs, IDEs, and technical files), ensuring timely approvals.

• Build and lead a scalable regulatory infrastructure, including processes, systems, and future team development as the company expands.

• Act as the primary liaison with FDA and global regulatory bodies, including leading audits, inspections, and key communications.

• Drive regulatory input into clinical strategy, product roadmaps, and labeling decisions to ensure compliance is built into the development process.

• Oversee regulatory review and approval of promotional materials, advertising claims, and customer-facing communications.

• Partner with Quality leadership to ensure our QMS meets global regulatory expectations and supports continuous improvement.

• Maintain visibility into evolving global regulatory requirements and proactively update internal stakeholders.

• Develop and manage domestic and international registration and listing activities.

• Support risk management, health hazard evaluations, and decision-making processes for field actions or advisory notices.

Who You Will Report To:

• General Counsel

Requirements:

• 12+ years of regulatory affairs experience in the medical device industry, including recent leadership-level responsibility.

• Proven success owning FDA submissions, including multiple 510(k)s or PMAs, and driving strategy through product development lifecycles.

• Expertise in reviewing and approving product claims and promotional content in a fast-paced, innovative environment.

• Strong understanding of U.S. regulatory requirements; familiarity with EU MDR and other international regulations preferred.

• Demonstrated ability to influence product and business strategy through a regulatory lens.

• Experience managing direct or matrixed teams, with a focus on development and scaling capabilities.

• Effective communicator and relationship-builder with cross-functional stakeholders and external regulators.

• Bachelor's degree in Life Sciences, Engineering, or related field required; advanced degree and/or RAC certification preferred.

• Travel: 5% travel may be required

• Full-time employment

• Must be able to sit for up to 8 hours/day

What We Offer:

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team. You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture. You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself.

We also offer a compensation plan as follows:

• Competitive salary with a base range of $220,000 - $240,000

• Stock options - ownership and a stake in growing a mission-driven company

• Employee benefits package that includes 401(k), healthcare insurance and paid time off

Calyxo is deeply committed to fostering an environment where diversity and inclusion are not only valued but also prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities, which strengthen our focus and fuel our growth. Calyxo is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics

Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify their identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.