Calyxo
Senior Regulatory Affairs Specialist - Pleasanton, CA
Pleasanton, CA · Senior
Sponsorship not specifiedDetected 1 day ago
ComplianceFDA RegulatoryMedical DevicesResearchLeadershipCommunicationRegulatory Affairs
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16Unrated
Cap-exempt (no lottery)0
Sponsors this role0
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
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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
- Prepare, author, and manage U.S. and international regulatory filings (including 510(k)s, letters to file, registrations/listings, and other regulatory submissions) with appropriate guidance for higher-risk or more complex issues, ensuring timely, high-quality deliverables.
- Support the development and continuous improvement of regulatory processes, systems, templates, and documentation practices to help scale the Regulatory Affairs function as the company grows.
- Serve as a key Regulatory Affairs representative on cross-functional teams and support communications with FDA and global regulatory bodies, including preparation for audits, inspections, and routine agency interactions.
- Provide regulatory input into product development and design enhancements-including biocompatibility, sterilization, packaging, shelf life, clinical strategy, product changes, and labeling decisions-to help ensure compliance is built into the development process.
- Support Operations and cost-reduction projects as assigned.
- Partner with Quality to support a QMS that meets global regulatory expectations and supports continuous improvement. Support compliance with FDA and other applicable regulations and regulating bodies.
- Support regulatory compliance activities such as CAPAs, NCMRs, complaints, and related post-market quality activities as needed.
- Maintain current knowledge of the regulatory landscape in order to provide sound regulatory input and day-to-day guidance to the business.
- Maintain visibility into evolving global regulatory requirements and support domestic and international registration and listing activities.
Requirements
- Prior experience with the FDA and/or other regulatory agencies is required.
- Proven success owning regulatory submissions such as 510(k)s and letters to file and supporting regulatory strategy through product development lif
- The ideal candidate brings solid FDA experience, working knowledge of global regulatory landscapes, and a proactive, collaborative mindset to navigating evolving regulatory requirements.
Benefits
- Support risk management activities, health hazard evaluations, and decision-making processes for field actions or advisory notices, with escalation of higher-risk matters as appropriate.
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.
This listing is sourced directly from Calyxo's careers page and normalized into a canonical job model.