Principal Regulatory Affairs Specialist

An innovative, venture-backed medical technology company in San Francisco is seeking a Principal Regulatory Affairs Specialist to join its growing regulatory organization. The company is developing a novel, highly technical medical device platform with the potential to meaningfully change how complex conditions are diagnosed and treated. This individual will play a key role in advancing new products and indications through development, regulatory submission, and commercialization. This is an excellent opportunity for an experienced Regulatory Affairs professional who enjoys working in an early-stage, fast-moving environment and wants significant ownership over regulatory strategy and execution. Key Responsibilities Develop and execute regulatory strategies for new medical devices, product modifications, and future indications. Serve as a core Regulatory Affairs representative on cross-functional product development programs. Lead preparation, coordination, and submission of regulatory documentation to the FDA. Support regulatory pathways including 510(k), De Novo, PMA, IDE, Pre-Submission/Q-Submission, and other applicable pathways depending on the program. Coordinate regulatory deliverables across engineering, clinical, quality, product, and executive stakeholders. Develop regulatory project plans, timelines, submission strategies, and risk mitigation plans. Provide regulatory guidance throughout the product development lifecycle, from early-stage design through verification, validation, submission, and commercialization. Review engineering and product changes to determine regulatory impact and required documentation or submissions. Partner with Clinical Affairs on clinical strategy, investigational requirements, and evidence generation supporting regulatory submissions. Participate in FDA interactions, including preparation for meetings, responses to agency questions, and management of follow-up activities. Support development and maintenance of technical documentation, regulatory records, and Design History File documentation. Ensure product development activities align with applicable FDA requirements, design controls, quality system requirements, and international regulatory standards. Track evolving regulations and guidance and communicate potential implications to internal teams. Help establish scalable regulatory processes as the company expands its product portfolio and clinical programs. Ideal Background Approximately 7+ years of Regulatory Affairs experience within medical devices or another highly regulated healthcare technology environment. Demonstrated experience developing and executing regulatory strategies for complex medical devices. Hands-on experience preparing and supporting FDA submissions. Strong understanding of the medical device development lifecycle and Design Controls. Experience working closely with engineering, quality, clinical, and product development teams. Comfortable managing multiple regulatory workstreams, timelines, and stakeholders simultaneously. Experience communicating directly with the FDA or supporting formal FDA interactions. Strong understanding of applicable regulations and standards, including areas such as: 21 CFR Part 820 / QMSR

ISO 13485

ISO 14971

IEC 62304

IEC 60601

Software and cybersecurity considerations for medical devices Particularly Relevant Experience Candidates with experience in one or more of the following areas will be especially relevant: Complex Class II or Class III medical devices Software-enabled medical devices or SaMD Imaging, diagnostic, therapeutic, or energy-based medical technologies Combination hardware/software systems Novel technologies requiring significant interaction with the FDA IDEs, clinical-stage devices, or products requiring clinical evidence Regulatory programs spanning early development through commercialization Start-up or growth-stage medical device environments What We're Looking For The ideal candidate is not simply a submission writer. This person should be able to understand a complex technology, determine the appropriate regulatory pathway, create a clear strategy, and then work cross-functionally to drive that strategy through execution. You should be comfortable operating with a high degree of ownership and working directly with technical teams in an environment where products and regulatory strategies continue to evolve. This position will have meaningful visibility across the organization and the opportunity to influence regulatory strategy for a potentially transformative medical technology platform. Full-time, on-site position in San Francisco Opportunity to join an emerging medical technology company at an important stage of product and clinical development #J-18808-Ljbffr Lumicity