What are the responsibilities and job description for the Senior Regulatory Affairs Specialist position at Lumicity?
This is an excellent opportunity in a growing startup developing products for the medical device industry and integrating AI. The focus is on actual content creation (e.g., 510(k) submissions), not management/ supervisory. Title available can be for a Senior RA Specialist or Principal RA Specialist.
If you have strong hands-on authoring experience and an interest in the SaMD/ AI space, get in touch!
Regulatory Strategy & Execution – Develop and refine the regulatory strategy for SaMD 510(k)/ De Novo submissions, ensuring compliance with FDA regulations and industry standards.
FDA Interaction & Documentation – Interpret FDA feedback, integrate recommendations into submission documents, and oversee the preparation of complete regulatory packages.
Cross-Functional Collaboration – Act as the primary regulatory liaison, coordinating efforts between product development teams and external experts in regulatory, clinical, and quality affairs.
Clinical & Technical Alignment – Work with clinical and technical teams to ensure study design, software documentation, and cybersecurity measures meet regulatory expectations.
Compliance & Quality Management – Maintain audit-ready documentation, review labeling strategies, and ensure adherence to QMS standards (e.g., ISO 13485) and FDA Quality System Regulations.
Stakeholder Communication – Provide regulatory updates to senior leadership, identify potential risks, and communicate mitigation strategies.
FDA Representation – Serve as the key contact for FDA communications, coordinating meetings, responding to inquiries, and ensuring seamless engagement with the agency.
Future Regulatory Planning – Anticipate and prepare for additional submissions (e.g., 510(k), PMA), staying ahead of industry trends and evolving FDA guidance.
Qualifications & Expertise – Require 4-7 years of regulatory experience in SaMD or AI-based medical devices, with a strong understanding of FDA regulations and clinical validation standards.
Preferred Skills – Strong project management, problem-solving, and communication abilities; experience with AI/ML validation, FDA interactions, and regulatory certification (e.g., RAC).
Salary : $100,000 - $160,000
