Calyxo
Regulatory Affairs Program Manager- Pleasanton, CA
Pleasanton, CA · Staff+
Sponsorship not specifiedDetected 20 hours ago
ComplianceNegotiationFDA RegulatoryMedical DevicesResearchCommunicationMentoringRegulatory Affairs
About the role
- Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA.
- 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.
Responsibilities
- Lead the strategy, preparation, submission, and negotiation of complex U.S. and international regulatory filings (including 510(k)s, Q-Subs/Pre-Submissions, Special 510(k)s, and Letters to File), ensuring timely approvals and serving as the technical lead on the most challenging submissions.
- Drive the development and continuous improvement of scalable regulatory infrastructure-including processes, systems, SOPs, and team capabilities-to support organizational growth and evolving compliance needs.
- Provide expert regulatory input into product development and design enhancements-including biocompatibility, sterilization, packaging, shelf life, clinical strategy, product roadmaps, and labeling decisions-to ensure compliance is built into the development process.
- Lead regulatory support for Operations and cost-reduction projects.
- Partner with Quality to ensure our QMS meets global regulatory expectations and supports continuous improvement. Ensure compliance with FDA and other applicable regulations and regulating bodies, including FDA QMSR transition activities.
- Mentor and develop junior Regulatory Affairs staff, providing technical guidance, review of deliverables, and coaching on regulatory strategy and submission excellence.
- This is a strategic, high-visibility role for a seasoned regulatory professional who can independently drive complex U.S. and international submissions, shape regulatory strategy across the product portfolio, and mentor junior team members.
- Maintain visibility into evolving global regulatory requirements and proactively update internal stakeholders. Develop and manage domestic and international registration and listing activities.
Requirements
- serve as a senior reviewer and approver where required.
- The ideal candidate brings deep FDA expertise, advanced command of global regulatory landscapes, and a proactive, collaborative mindset to navigating complex, evolving regulatory environments.
Benefits
- Lead risk management, health hazard evaluations, and decision-making processes for field actions, recalls, or advisory notices.
Company info
- The company was founded in 2016 to address the profound need for improved kidney stone treatment.
- 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.
- We are seeking an accomplished Lead Regulatory Affairs Specialist to serve as a senior individual contributor and subject matter expert within our growing Regulatory Affairs organization.
This listing is sourced directly from Calyxo's careers page and normalized into a canonical job model.