Associate Director IVD Quality

Job Title: Associate Director IVD Quality

Location: On Site - San Diego, California, United States

Salary: $160,000-$200,000

Skills: IVD quality management, QMS implementation, FDA/ISO 13485 compliance, regulatory submissions, cross-functional leadership

About the Biotechnology Research Company / The Opportunity:

Join a dynamic, rapidly growing leader in the biotechnology research sector, focused on driving innovation in in vitro diagnostics (IVD). This opportunity puts you at the forefront of quality initiatives impacting both development-stage and commercial diagnostic products. As Associate Director IVD Quality, you will shape quality strategy in a high-visibility leadership role, collaborating closely with executive teams and influencing the future of advanced diagnostics in a mission-driven, fast-paced environment.

Responsibilities:

• Lead and maintain the Quality Management System in full compliance with 21 CFR Part 820, ISO 13485, and global regulatory requirements.
• Oversee quality operations across the entire product lifecycle, including design controls, risk management, and post-market activities.
• Support regulatory submissions such as 510(k), PMA, and IVDR from a quality perspective, ensuring smooth interactions with health authorities.
• Drive internal and external audit readiness, including FDA inspections and notified body audits, ensuring continual compliance.
• Lead CAPA, deviation, and nonconformance processes to ensure timely resolution and promote continuous improvement.
• Build, mentor, and scale a high-performing quality team to support organizational growth.
• Collaborate cross-functionally with Regulatory, R&D, Clinical, and Manufacturing teams to embed quality across all operations.

Must-Have Skills:

• Bachelor’s degree in a scientific or engineering field (advanced degree preferred).
• 8 years of experience in Quality for medical devices or diagnostics, including significant IVD experience.
• Proven expertise in QMS implementation and maintenance within regulated environments.
• Deep knowledge of FDA and international regulatory requirements (ISO 13485, IVDR).
• Experience supporting regulatory submissions and direct interactions with health authorities.
• Strong leadership experience with the ability to influence and communicate across cross-functional teams.

Nice-to-Have Skills:

• Advanced degree in life sciences, engineering, or a related field.
• Experience building and scaling quality teams in a high-growth environment.
• Hands-on involvement with post-market activities and product lifecycle management.
• Background in both U.S. and international regulatory submissions for IVD products.
• Expertise in risk management and continuous improvement methodologies such as Six Sigma or Lean.