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

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.

• Building, implementing, and maintaining a scalable electronic QMS (Green Light 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

• 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

$/yr – $/yr

Lake Forest, CA area | 100% Onsite

Director

Full-time

Engineering and Quality Assurance

Medical Equipment Manufacturing and Pharmaceutical Manufacturing

• Medical insurance
• Vision insurance
• 401(k)