Summary:  

We are seeking an accomplished Staff Regulatory Affairs Specialist to 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 FDA expertise, advanced command of global regulatory landscapes, and a proactive, collaborative mindset to navigating complex, evolving regulatory environments. As a senior 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: 

• 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), ensuring timely approvals and serving as the technical lead on the most challenging submissions. 

• Drive the development and continuous improvement of scalable regulatory infrastructure—including processes, systems, SOPs, and team capabilities—to support organizational growth and evolving compliance needs. 

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

• Provide expert regulatory input into product development and design enhancements—including biocompatibility, sterilization, packaging, shelf life, clinical strategy, product roadmaps, and labeling decisions—to 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/eMDR processes; serve as a senior reviewer and approver where required. 

• Mentor and develop junior Regulatory Affairs staff, providing technical 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 and expertise of the regulatory landscape in order to provide expert input and guidance to the business, and serve as the in-house subject matter expert on FDA medical device regulations and selected international jurisdictions. 

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 prior experience interfacing with the FDA and/or other regulatory agencies is required. 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 matter expertise in providing regulatory 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 regulations required. U.S. and European/International regulations and standards knowledge is required. 

• 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 device eQMS is required. 

• 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. 

• Bachelor's degree in Life Sciences, Engineering, or related field required; advanced degree and/or RAC certification strongly preferred. 

• Travel: 5% travel may be required 

• Location: Pleasanton office (minimum 3-days a week onsite) 

• 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 salary of $160,000 - $175,000 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 

Summary:  

The Clinical Project Manager plays a critical role in leading the execution of clinical trials from start to finish. This position ensures trials are conducted efficiently, on time, and in full compliance with regulatory requirements. This position collaborates closely with internal stakeholders and external partners—including CRAs, CROs, and clinical sites—to generate high-quality clinical evidence that informs product development and regulatory strategy. This is a hands-on role within a fast-paced, team-driven environment, ideal for candidates who thrive in dynamic settings and have a passion for operational excellence in clinical research.  

In This Role, You Will: 

• Ability to effectively manage clinical studies to support the clinical operation goals that align with the company’s visions for evidence generation 
• Ensure clinical research is conducted in accordance with 21 CFR Part 812, 50 and 56 and applicable international standards (ISO 14155:2026) 
• Identify, evaluate and qualify clinical sites to ensure compliance with applicable regulatory regulations 
• Assist in negotiating clinical site budgets and study contracts 
• Prepare clinical monitoring guidelines 
• Generate various study and training materials to support clinical trials 
• Source, manage and train contract CRAs assigned to study sites 
• Review and approve CRA monitoring trip reports 
• Conduct site initiation visits and monitoring visits, and provide clinical trial related training for RCs, Investigators, OR staff, etc. 
• Provide surgical technique training and proctor clinical cases at hospital and ASC facilities 
• Plan and conduct investigator meetings 
• Assist in identifying, evaluating and managing CROs or vendors for study related services including but limited to: data management, statistical analysis, monitoring 
• Provide technical eDC and clinical support during clinical research 
• Monitor clinical study data and assist in cleaning of eDC and other study databases 
• Develop project management tools to manage clinical projects 
• Develop study tracking tools and metrics and report to management 
• Conduct and summarize literature reviews in support of clinical activities 
• Assist with coordination of data analysis and prepare clinical reports to support regulatory filings 
• Assist with development of clinical strategy, which includes the preparation of clinical protocols and investigational plans. 
• Other duties may be assigned as a part of job scope 

Who You Will Report To: 

• Sr. Director, Clinical Operations

Requirements: 

• Degree in a life science (BS or MS) 
• 7+ years of relevant clinical experience in medical devices (or a combination of pharma and med devices)   
• At least four years of full-cycle clinical project management experience. 
• Intimate working knowledge of US clinical research and medical device regulations.  
• Ability to effectively work cross-functionally with multiple departments; manage completion of multiple tasks.   
• Ability to prioritize projects and display initiative and flexibility.   
• Detail oriented, strong people and organizational skills.  
• Strong medical background and understanding of the fundamentals of clinical research and statistical methodology.  Background in urology research preferable.  
• Proficient with PC and associated software. Strong technical, written and communication skills. 
• Ability to travel up to 50% of the time 
• Proficiency in Power Point, Excel and eDC platforms 
• 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 range of $140,000 - $150,000 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