Regulatory Affairs Specialist - Pleasanton, CA

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 an experienced Regulatory Affairs Specialist to support our growing organization. This is a high-impact role at a pivotal stage in our company's growth. 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 Regulatory Team, you'll work closely with Research & Development, Operations, 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:

• Lead the preparation, submission, and negotiation of U.S. and international regulatory filings (including 510(k)s, letters to file), ensuring timely approvals.
• Support building 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 supporting audits, inspections, and key communications.
• Drive regulatory input and provide expertise into areas of product development/design enhancements such as biocompatibility, sterilization, packaging, shelf life, clinical strategy, product roadmaps, and labeling decisions to ensure compliance is built into the development process. Support Operations/cost cutting projects.
• Oversee regulatory review and approval of promotional materials, advertising claims, and customer-facing communications.
• Partner with Quality to ensure our QMS meets global regulatory expectations and supports continuous improvement. Ensure compliance to FDA and other applicable regulations and regulating bodies.
• Monitor proposed regulatory changes from the FDA and other agencies including worldwide regulatory authorities
• 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.
• Support regulatory compliance activities as needed such as CAPAs, NCMR’s etc.
• Maintain current knowledge and expertise of the regulatory landscape in order to provide expert input and guidance to the business.

Who You Will Report To:

• See Organizational Chart

Requirements:

• Minimum 5+ years’ experience regulatory affairs in medical device, pharmaceutical or biotechnology or in-vitro diagnostics (IVD) industry, including Class II or Class III electromechanical medical devices.
• Prior experience with the FDA and/or other regulatory agencies is required. Proven success owning FDA submissions, including multiple 510(k)s or PMAs, and driving strategy through product development lifecycles.
• Expertise in providing regulatory guidance for biocompatibility, packaging, sterilization, labeling etc. and 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. U.S. and/or European/International regulations and standards knowledge is required.
• Demonstrated ability to work with cross functional teams, excellent technical writing skills.
• Proven analytical capabilities, solid understanding of manufacturing, change control, and awareness of regulatory industry trends. Experience with medical device eQMS is required.
• 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
• Location: Pleasanton office (in-person or hybrid)
• Must be able to sit for up to 8 hours/day
• Compliance with relevant county, state, and Federal rules regarding vaccinations.

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 an attractive compensation package, which includes:

• A competitive base salary of $115,000 - $135,000 and variable incentive plan
• Stock options – ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid vacation

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. 

Disclaimer:

At Calyxo, we prioritize a transparent and structured interview process to ensure the best fit for both our candidates and our team. Please be aware of the following:

• Structured Interview Process: Our hiring process includes multiple stages of interviews where you will have the opportunity to communicate directly with Calyxo employees. This ensures that you gain a comprehensive understanding of the role and our company culture.
• Verification of Identity: We do not extend job offers without first meeting candidates, either virtually or in person. This step is crucial to maintain the integrity of our hiring process and to ensure mutual alignment.
• Beware of Scams: Calyxo will never request sensitive personal information, such as your full name, address, phone number, or identification documents, via email or online forms before an official interview. Calyxo representatives will always contact you using an email format of firstname.lastname@calyxoinc.com. If you receive a request for information from any other domain, please contact us directly at info@calyxoinc.com to verify the legitimacy of the communication.

We appreciate your interest in joining Calyxo and look forward to getting to know you through our official channels.