Staff 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 accomplishedStaff Regulatory Affairs Specialistto serve as a senior individual contributor and subject matter expert within our growing Regulatory Affairs organization. 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. The ideal candidate brings deep FDAexpertise advanced command of global regulatory landscapes and a proactive collaborative mindset to navigating complex evolving regulatory environments. As a senior member of theCalyxoRegulatory Team you will work closely with Research & Development Operations Quality Clinical and Medical Affairs Marketing and Legal to ensure regulatory alignment from concept through commercializationbalancing speed with compliance as we bring category-defining medical devices to market.

In This Role You Will:

• 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) ensuringtimelyapprovals and serving as the technical lead on the most challenging submissions.

• Drive the development and continuous improvement of scalable regulatory infrastructureincluding processes systems SOPs and team capabilitiesto support organizational growth and evolving compliance needs.

• Act as a primary liaison with FDA and global regulatory bodies leading audits inspections and key communications andrepresentingCalyxowith confidence and technical authority.

• Provide expert regulatory input into product development and design enhancementsincluding biocompatibility sterilization packaging shelf life clinical strategy product roadmaps and labeling decisionsto ensure compliance is built into the development process. Lead regulatory support for Operations and cost-reduction projects.

• Oversee regulatory review and approval of promotional materials advertising claims and customer-facing communications owning the claims matrix and serving as final regulatory reviewer.

• 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.

• Monitor and interpret proposed regulatory changes from the FDA and other agencies including worldwide regulatory authorities and translate them into actionable guidance for the business.

• Maintain visibility into evolving global regulatory requirements and proactively update internal stakeholders. Develop and manage domestic and international registration and listing activities.

• Lead risk management health hazard evaluations and decision-making processes for field actions recalls or advisory notices.

• Drive regulatory compliance activities such as CAPAs NCMRs complaints and MDR/eMDRprocesses; serve as a senior reviewer and approver whererequired.

• Mentor and develop junior Regulatory Affairs staffprovidingtechnical guidance review of deliverables and coaching on regulatory strategy and submission excellence.

• Champion a culture of regulatory excellence knowledge sharing and continuous improvement across the Regulatory Affairs function.

• Maintain current knowledge andexpertiseof the regulatory landscapein order toprovide expert input and guidance to thebusiness andserve as the in-house subject matter expert on FDA medical device regulations and selected internationaljurisdictions.

Who You Will Report To:

• Director Regulatory Affairs

Requirements:

• 12 years experience in regulatory affairs in medical device biotechnology or in-vitro diagnostics (IVD) industry including substantial experience with Class II or Class III electromechanical medical devices.

• Extensive priorexperienceinterfacing with the FDA and/or other regulatory agencies isrequired. Proven success independently leading multiple FDA submissions including 510(k)s Special 510(k)s Q-Subs and/or PMAs and driving regulatory strategy through full product development lifecycles.

• Recognized subject matterexpertiseinprovidingregulatory guidance for biocompatibility packaging sterilization software (IEC 62304) electrical safety and EMC (IEC 60601) labeling and reviewing and approving product claims and promotional content in a fast-paced innovative environment.

• Advanced understanding of U.S. regulatory requirements; working knowledge of EU MDR and other international regulationsrequired. U.S. and European/International regulations and standards knowledgeisrequired.

• Demonstrated ability to lead and influence cross-functional teams with excellent technical writing skills and a strong record of authoring high-quality regulatory submissions and Letters to File.

• Strong analytical capabilities deep understanding of design controls manufacturing change control and awareness of regulatory industry trends. Experience with medical deviceeQMSisrequired.

• Proven mentor and coach able to develop junior regulatory talent and elevate team capability through knowledge sharing and structured review.

• Effective communicator and relationship-builder with cross-functional stakeholders executive leadership and external regulators.

• Bachelors degree in Life Sciences Engineering or related fieldrequired; advanced degree and/or RAC certificationstronglypreferred.

• Travel: 5% travel may berequired

• Location: Pleasanton office (minimum3-days a week onsite)

• Must be able to sit for up to 8 hours/day

• Compliance with relevant county state and Federal rulesregardingvaccinations.

WhatWeOffer:

AtCalyxo you will be part of a knowledgeable high-achievingexperiencedand 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 offeran attractivecompensation package which includes:

• A competitive salary of $160000 - $175000and variable incentive plan

• Stock options ownership and a stake in growing amission-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 onlyvalued but alsoprioritized. 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 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. If you receive a request for information from any other domain please contact us directly at 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.