Senior Regulatory Affairs Specialist - Pleasanton, CA

Summary:  

We are seeking an experienced Senior Regulatory Affairs Specialist to support our growing 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. 

In This Role, You Will: 

• 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. 

• 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. 

• 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. 

• Monitor proposed regulatory changes from the FDA and other agencies, including worldwide regulatory authorities, and communicate relevant updates to internal stakeholders. 

• Maintain visibility into evolving global regulatory requirements and support domestic and international registration and listing activities. 

• 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. 

• 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. 

Who You Will Report To: 

•  Director, Regulatory Affairs

Requirements: 

• 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.

• 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. 

• 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. 

• 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 effectively with cross-functional teams, with strong technical writing, organizational, and communication 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. 

• Bachelor's 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 $145,000 - $160,000 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