Sr. 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 experienced Senior Regulatory Affairs Specialist to support our growing organization. This is a high-impact role at a pivotal stage in our companys growth. The ideal candidate brings deep FDA expertise a strong command of global regulatory landscapes and a proactive collaborative mindset to navigating complex evolving regulatory environments. As a member of the Calyxo Regulatory Team youll 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 preparation submission and negotiation of U.S. and international regulatory filings (including 510(k)s letters to file) ensuring timely approvals.
• Drive the development of scalable regulatory infrastructureincluding processes systems and team capabilitiesto support organizational growth and evolving compliance needs.
• 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 areas of 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 cutting 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 with FDA and other applicable regulations and regulating bodies.
• Monitor proposed regulatory changes from the FDA and other agencies including worldwide regulatory authorities
• Maintain visibility into evolving global regulatory requirements and proactively 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 in order to provide expert input and guidance to the business.

Who You Will Report To:

• Director Regulatory Affairs

Requirements:

• 8 years experience regulatory affairs in medical device pharmaceutical or biotechnology or in-vitro diagnostics (IVD) industry including Class II or Class III electromechanical medical devices.
• Prior experience with the FDA and/or other regulatory agencies is required. Proven success owning FDA submissions including multiple 510(k)s or PMAs and driving strategy through product development lifecycles.
• Expertise in providing regulatory guidance for biocompatibility packaging sterilization labeling etc. and reviewing and approving product claims and promotional content in a fast-paced innovative environment.
• 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.
• Demonstrated ability to work with cross functional teams excellent technical writing skills.
• Proven analytical capabilities solid understanding of manufacturing change control and awareness of regulatory industry trends. Experience with medical device eQMS is required.
• Effective communicator and relationship-builder with cross-functional stakeholders and external regulators.
• Bachelors degree in Life Sciences Engineering or related field required; advanced degree and/or RAC certification preferred.
• Travel: 5% travel 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 rules regarding vaccinations.

What We Offer:

At Calyxo you will be part of a knowledgeable high-achieving experienced and 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 offer an attractive compensation package which includes:

• A competitive base salary of $130000 - $145000 and variable incentive plan
• Stock options ownership and a stake in growing a mission-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.