Senior Regulatory Affairs Specialist - Pleasanton, CA

<div class="content-intro"><p>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.</p> <p>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.</p></div><p><strong><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Summary:</span><span data-ccp-parastyle="Normal (Web)"> </span></span></strong><span data-ccp-props="{"134233117":true,"134233118":true,"335557856":16777215}"> </span></p> <p><span data-contrast="none">We are seeking an experienced Senior Regulatory Affairs Specialist to support our growing</span> <span data-contrast="none">Regulatory Affairs organization. This is a high-impact individual contributor role for a regulatory professional who can independently manage core regulatory activities, own moderately complex U.S. and international submissions, and provide strong cross-functional support across product development and sustaining activities. The ideal candidate brings solid FDA experience, working knowledge of global regulatory landscapes, and a proactive, collaborative mindset to navigating evolving regulatory requirements. As a member of the Calyxo Regulatory Team, you will 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.</span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335557856":16777215,"335559738":240,"335559739":240,"335559740":276}"> </span></p> <p><strong><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">In This Role, You Will</span><span data-ccp-parastyle="Normal (Web)">:</span></span></strong><span data-ccp-props="{"134233117":true,"134233118":true,"335557856":16777215}"> </span></p> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="49" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none">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.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":240,"335559739":240}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="49" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="none">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.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":0,"335559738":0,"335559739":0}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="49" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="none">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.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":0,"335559738":0,"335559739":0}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="49" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="none">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.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":0,"335559738":0,"335559739":0}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="49" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1"><span data-contrast="none">Conduct regulatory review of promotional materials, advertising claims, and customer-facing communications in partnership with Regulatory Affairs leadership, ensuring consistency with approved claims and regulatory requirements.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":0,"335559738":0,"335559739":0}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="49" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="6" data-aria-level="1"><span data-contrast="none">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.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":0,"335559738":0,"335559739":0}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="49" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="7" data-aria-level="1"><span data-contrast="none">Monitor proposed regulatory changes from the FDA and other agencies, including worldwide regulatory authorities, and communicate relevant updates to internal stakeholders.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":0,"335559738":0,"335559739":0}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="49" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="8" data-aria-level="1"><span data-contrast="none">Maintain visibility into evolving global regulatory requirements and support domestic and international registration and listing activities.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":0,"335559738":0,"335559739":0}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="49" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="9" data-aria-level="1"><span data-contrast="none">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.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":0,"335559738":0,"335559739":0}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="49" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="10" data-aria-level="1"><span data-contrast="none">Support regulatory compliance activities such as CAPAs, NCMRs, complaints, and related post-market quality activities as needed.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":0,"335559738":0,"335559739":0}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="49" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="11" data-aria-level="1"><span data-contrast="none">Maintain current knowledge of the regulatory landscape in order to provide sound regulatory input and day-to-day guidance to the business.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":0,"335559738":0,"335559739":0}"> </span></li> </ul> <p><span data-ccp-props="{"134233117":false,"134233118":false,"335557856":16777215,"335559738":0,"335559739":0}"> </span></p> <p><strong><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Who You Will Report To:</span></span></strong><span data-ccp-props="{"134233117":false,"134233118":false,"335557856":16777215,"335559738":0,"335559739":0}"> </span></p> <p><span data-ccp-props="{"134233117":false,"134233118":false,"335557856":16777215,"335559738":0,"335559739":0}"> </span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="37" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)"> Director, Regulatory Affairs</span></span></li> </ul> <p><span data-ccp-props="{"134233117":false,"134233118":false,"335557856":16777215,"335559738":0,"335559739":0}"> </span></p> <p><strong><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Requirements</span><span data-ccp-parastyle="Normal (Web)">:</span></span></strong><span data-ccp-props="{"134233117":false,"134233118":false,"335557856":16777215,"335559738":0,"335559739":0}"> </span></p> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="33" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">Master's degree with a minimum of 5 years of directly relevant regulatory affairs experience, or Bachelor's degree with a minimum of 8 years of directly relevant regulatory affairs experience, in the medical device, pharmaceutical, biotechnology, or in vitro diagnostics (IVD) industry, including experience with Class II or Class III electromechanical medical devices.</li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="33" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="none">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 lifecycles.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":0,"335559738":0,"335559739":0}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="33" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="none">Experience providing regulatory guidance in areas such as biocompatibility, packaging, sterilization, labeling, and review of product claims and promotional content in a fast-paced, innovative environment.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":0,"335559738":0,"335559739":0}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="33" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="none">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.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":0,"335559738":0,"335559739":0}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="33" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1"><span data-contrast="none">Demonstrated ability to work effectively with cross-functional teams, with strong technical writing, organizational, and communication skills.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":0,"335559738":0,"335559739":0}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="33" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="6" data-aria-level="1"><span data-contrast="none">Proven analytical capabilities, solid understanding of manufacturing, change control, and awareness of regulatory industry trends. Experience with medical device eQMS is required.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":0,"335559738":0,"335559739":0}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="33" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="7" data-aria-level="1"><span data-contrast="none">Effective communicator and relationship-builder with cross-functional stakeholders and external regulators.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":0,"335559738":0,"335559739":0}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="33" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="8" data-aria-level="1"><span data-contrast="none">Bachelor's degree in Life Sciences, Engineering, or related field required; advanced degree and/or RAC certification preferred.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":0,"335559738":0,"335559739":0}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="33" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="9" data-aria-level="1"><span data-contrast="none">Travel: 5% travel may be required</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":0,"335559738":0,"335559739":0}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="33" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="10" data-aria-level="1"><span data-contrast="none">Location: Pleasanton office (in-person or hybrid)</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":0,"335559738":0,"335559739":0}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="33" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="11" data-aria-level="1"><span data-contrast="none">Must be able to sit for up to 8 hours/day</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":0,"335559738":0,"335559739":0}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="33" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="12" data-aria-level="1"><span data-contrast="none">Compliance with relevant county, state, and Federal rules regarding vaccinations.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":0,"335559738":0,"335559739":0}"> </span></li> </ul> <p><span data-ccp-props="{}"> </span></p> <p><strong><span data-contrast="auto"><span data-ccp-parastyle="No Spacing">What </span><span data-ccp-parastyle="No Spacing">W</span><span data-ccp-parastyle="No Spacing">e </span><span data-ccp-parastyle="No Spacing">O</span><span data-ccp-parastyle="No Spacing">ffer</span><span data-ccp-parastyle="No Spacing">:</span></span></strong><span data-ccp-props="{}"> </span></p> <p><span data-ccp-props="{}"> </span></p> <p><span data-contrast="auto"><span data-ccp-parastyle="No Spacing">At </span><span data-ccp-parastyle="No Spacing">Calyxo</span><span data-ccp-parastyle="No Spacing">, you will be part of a knowledgeable, high-achieving, </span><span data-ccp-parastyle="No Spacing">experienced</span><span data-ccp-parastyle="No Spacing"> and fun team</span><span data-ccp-parastyle="No Spacing">.  </span><span data-ccp-parastyle="No Spacing">You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture</span><span data-ccp-parastyle="No Spacing">.  </span><span data-ccp-parastyle="No Spacing">You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself</span><span data-ccp-parastyle="No Spacing">.  </span></span><span data-ccp-props="{}"> </span></p> <p><span data-ccp-props="{}"> </span></p> <p><span data-contrast="auto"><span data-ccp-parastyle="No Spacing">We also offer </span><span data-ccp-parastyle="No Spacing">an attractive</span><span data-ccp-parastyle="No Spacing"> compensation package, which includes</span><span data-ccp-parastyle="No Spacing">:</span></span><span data-ccp-props="{}"> </span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="36" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="No Spacing">A c</span><span data-ccp-parastyle="No Spacing">ompetitive </span><span data-ccp-parastyle="No Spacing">base </span><span data-ccp-parastyle="No Spacing">salary</span><span data-ccp-parastyle="No Spacing"> of $145,000 - $160,000 and variable incentive plan</span><span data-ccp-parastyle="No Spacing"> </span></span><span data-ccp-props="{}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="36" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="No Spacing">Stock options – ownership and a stake in growing a</span><span data-ccp-parastyle="No Spacing"> mission-driven company</span></span><span data-ccp-props="{}"> </span></li> <li data-leveltext="" data-font="Symbol" data-listid="36" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="No Spacing">Employee benefits package that includes 401(k), healthcare insurance and paid vacation</span></span><span data-ccp-props="{}"> </span></li> </ul><div class="content-conclusion"><p><span class="TextRun SCXW190299773 BCX0" lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW190299773 BCX0">Calyxo is deeply committed to fostering an environment where diversity and inclusion are not only </span><span class="NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW190299773 BCX0">valued but also</span><span class="NormalTextRun SCXW190299773 BCX0"> prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to </span><span class="NormalTextRun SCXW190299773 BCX0">impact</span><span class="NormalTextRun SCXW190299773 BCX0"> people in big ways. Diverse viewpoints bring diverse capabilities, which strengthen our focus and fuel our growth.</span></span><span class="LineBreakBlob BlobObject DragDrop SCXW190299773 BCX0"><span class="SCXW190299773 BCX0"> </span><br class="SCXW190299773 BCX0"></span><span class="LineBreakBlob BlobObject DragDrop SCXW190299773 BCX0"><span class="SCXW190299773 BCX0"> </span><br class="SCXW190299773 BCX0"></span><span class="TextRun SCXW190299773 BCX0" lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW190299773 BCX0">Calyxo is proud to be an equal opportunity employer, </span><span class="NormalTextRun SCXW190299773 BCX0">seeking</span><span class="NormalTextRun SCXW190299773 BCX0"> 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 </span><span class="NormalTextRun SCXW190299773 BCX0">status</span><span class="NormalTextRun SCXW190299773 BCX0"> or any other applicable legally protected characteristics</span></span></p> <p>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. </p> <p></p> <p class="x_MsoNormal"><strong><span data-olk-copy-source="MessageBody">Disclaimer:</span></strong></p> <p class="x_MsoNormal">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:</p> <ul type="disc"> <li class="x_MsoNormal"><strong>Structured Interview Process</strong>: 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.</li> <li class="x_MsoNormal"><strong>Verification of Identity</strong>: 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.</li> <li class="x_MsoNormal"><strong>Beware of Scams</strong>: 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 <a href="mailto:firstname.lastname@calyxoinc.com" data-linkindex="1">firstname.lastname@calyxoinc.com</a>. If you receive a request for information from any other domain, please contact us directly at info@calyxoinc.com<strong> </strong>to verify the legitimacy of the communication.</li> </ul> <p class="x_MsoNormal">We appreciate your interest in joining Calyxo and look forward to getting to know you through our official channels.</p> <p></p></div>