Staff Regulatory Affairs Specialist - Pleasanton, CA

About the role

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.

Responsibilities

• 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.
• 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.

Qualifications

• 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.

Benefits

• 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

Pay

$160,000 - $175,000

Schedule

Minimum 3-days a week onsite in Pleasanton, CA