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Kelly Science, Engineering, Technology & Telecom · 1 day ago

Senior Director of Quality Assurance & Regulatory Affairs

Lake Forest, CA

Full-time

Onsite

Director/Executive

$180K/yr - $240K/yr

10+ years exp

Kelly Science, Engineering, Technology & Telecom is partnering with a fast-growing medical device startup to hire a Senior Director of Quality Assurance & Regulatory Affairs. This foundational leadership role involves building the quality and regulatory functions from the ground up, ensuring FDA readiness, and working closely with executive leadership in a fast-paced environment.

Staffing & Recruiting

Hiring Manager

Patty Diaz

Responsibilities

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

Qualification

Quality Management SystemsRegulatory AffairsFDA SubmissionsMedical Device ExperienceISO 13485ISO 14971Risk ManagementLeadershipCommunicationDetail-oriented