Senior Director of Quality Assurance & Regulatory Affairs

Senior Director of Quality Assurance & Regulatory Affairs Kelly Engineering is partnering with a fast‑growing medical device startup to hire a Senior Director of Quality Assurance & Regulatory Affairs. This is a foundational leadership role for someone who wants to build quality and regulatory from the ground up and play a critical role in bringing a new medical device to market. Lake Forest, CA area | 100% Onsite Now Hiring: Senior Director of Quality Assurance & Regulatory Affairs The Opportunity This role will serve as the first and most senior QA/RA leader at the company. You will own the entire quality and regulatory function end‑to‑end and work directly with executive leadership in a highly hands‑on, fast‑paced startup environment. If you enjoy building systems from scratch, working closely with engineering teams, and being accountable for FDA readiness, this role offers a rare chance to shape quality culture from day one. What You’ll Be Responsible For Building, implementing, and maintaining a scalable electronic QMS (GreenLight Guru experience strongly preferred) Establishing SOPs, policies, and documentation required for FDA and international compliance Leading Design Controls and ownership of the DHF Establishing Risk Management, CAPA, Nonconformance, Internal Audit, and Compliance systems Preparing the organization for FDA and Notified Body audits Leading regulatory strategy and submissions for Class II devices, including 510(k) and Q‑Sub / Pre‑Sub interactions Acting as the primary point of contact with the FDA Ensuring compliance with 21 CFR Part 820 as a core priority Supporting future compliance with EU MDR and other global regulations Partnering closely with R&D, leadership, and external consultants Training internal teams on QA/RA expectations and processes Providing QA/RA guidance to executives and investors Hiring and mentoring future QA/RA team members as the company scales Serving as a calm, credible leader during audits and inspections What We’re Looking For Bachelor’s degree in Engineering, Life Sciences, or a related field 10+ years of Quality and Regulatory experience in medical devices 3+ years in early‑ to mid‑stage startup environments Proven experience building or significantly upgrading an eQMS Direct experience with FDA submissions (510(k), Q‑Subs) Strong knowledge of 21 CFR Part 820, ISO 13485, ISO 14971 Experience with hardware and software‑based medical devices (AI experience is a plus) Comfortable working with ambiguity and limited resources Hands‑on, detail‑oriented, and strategically minded Strong communicator with regulatory agencies and cross‑functional teams High integrity and accountability Salary Range $180,000.00/yr – $240,000.00/yr Location Lake Forest, CA area | 100% Onsite Seniority Level Director Employment Type Full-time Job Function Engineering and Quality Assurance Industries Medical Equipment Manufacturing and Pharmaceutical Manufacturing Benefits Medical insurance Vision insurance 401(k) #J-18808-Ljbffr Kelly Science, Engineering, Technology & Telecom