Calyxo, Inc.
Regulatory Affairs Specialist - Pleasanton, CA
Calyxo, Inc., Pleasanton, California, United States, 94566
Overview
Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the need for improved kidney stone treatment. Our team is led by executives and investors with a track record of commercializing devices to meet unmet needs within urology. We are seeking high achievers to join a dynamic team in a diverse atmosphere. 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 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 reduction 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 worldwide and 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, NCMRs, etc. Maintain current knowledge and expertise of the regulatory landscape to provide expert input and guidance to the business. Who You Will Report To
See Organizational Chart Requirements
Minimum 5+ years’ experience in regulatory affairs for medical devices, pharmaceuticals, biotechnology, or in-vitro diagnostics (IVD), including Class II or Class III electromechanical medical devices. Prior experience with the FDA and/or other regulatory agencies; proven success owning FDA submissions (e.g., multiple 510(k)s or PMAs) and driving strategy through product development lifecycles. Expertise in regulatory guidance for biocompatibility, packaging, sterilization, labeling, etc., and reviewing/approving product claims and promotional content in a fast-paced environment. Strong understanding of U.S. regulatory requirements; familiarity with EU MDR and international regulations preferred. U.S. and/or European/International regulations and standards knowledge required. Demonstrated ability to work with cross-functional teams and excellent technical writing skills. Proven analytical abilities with understanding of manufacturing, change control, and 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% 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 vaccination requirements. What We Offer
A competitive base salary of $115,000 - $135,000 and a variable incentive plan Stock options – ownership in a mission-driven company Employee benefits package including 401(k), healthcare insurance, and paid vacation Equal Opportunity and Compliance
Calyxo is an equal opportunity employer. All applicants will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other 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 identity and eligibility to work in the United States. Disclaimer
We prioritize a transparent and structured interview process. The following notes may be helpful during your application: Structured Interview Process: Multiple interview stages to understand role and company culture. Verification of Identity: We may require meeting candidates virtually or in person before an offer is made. Beware of scams: Do not share sensitive personal information via email or online forms before an official interview. Communications from Calyxo will come from the domain @calyxoinc.com. If in doubt, contact info@calyxoinc.com to verify legitimacy. We appreciate your interest in joining Calyxo and look forward to connecting through our official channels.
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Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the need for improved kidney stone treatment. Our team is led by executives and investors with a track record of commercializing devices to meet unmet needs within urology. We are seeking high achievers to join a dynamic team in a diverse atmosphere. 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 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 reduction 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 worldwide and 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, NCMRs, etc. Maintain current knowledge and expertise of the regulatory landscape to provide expert input and guidance to the business. Who You Will Report To
See Organizational Chart Requirements
Minimum 5+ years’ experience in regulatory affairs for medical devices, pharmaceuticals, biotechnology, or in-vitro diagnostics (IVD), including Class II or Class III electromechanical medical devices. Prior experience with the FDA and/or other regulatory agencies; proven success owning FDA submissions (e.g., multiple 510(k)s or PMAs) and driving strategy through product development lifecycles. Expertise in regulatory guidance for biocompatibility, packaging, sterilization, labeling, etc., and reviewing/approving product claims and promotional content in a fast-paced environment. Strong understanding of U.S. regulatory requirements; familiarity with EU MDR and international regulations preferred. U.S. and/or European/International regulations and standards knowledge required. Demonstrated ability to work with cross-functional teams and excellent technical writing skills. Proven analytical abilities with understanding of manufacturing, change control, and 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% 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 vaccination requirements. What We Offer
A competitive base salary of $115,000 - $135,000 and a variable incentive plan Stock options – ownership in a mission-driven company Employee benefits package including 401(k), healthcare insurance, and paid vacation Equal Opportunity and Compliance
Calyxo is an equal opportunity employer. All applicants will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other 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 identity and eligibility to work in the United States. Disclaimer
We prioritize a transparent and structured interview process. The following notes may be helpful during your application: Structured Interview Process: Multiple interview stages to understand role and company culture. Verification of Identity: We may require meeting candidates virtually or in person before an offer is made. Beware of scams: Do not share sensitive personal information via email or online forms before an official interview. Communications from Calyxo will come from the domain @calyxoinc.com. If in doubt, contact info@calyxoinc.com to verify legitimacy. We appreciate your interest in joining Calyxo and look forward to connecting through our official channels.
#J-18808-Ljbffr