Design Control Lead, Molecular Diagnostics Scientist

Abbott Laboratories; San Diego (CA); On-site; USD 114,000 - 228,000; Full time

Benefits offered by this job

Free medical coverage in HIP PPO

Excellent retirement plan

Tuition reimbursement

FreeU education benefit

Job summary

Abbott Laboratories is seeking a Staff Research Scientist to lead design control activities and manage regulatory submissions for regulated molecular diagnostics products. You will oversee DHF management, design reviews, risk management, and phase-gate governance across the product development lifecycle.

You will collaborate with R&D, Quality, Regulatory Affairs, Clinical Affairs, Manufacturing, and Product Management to ensure FDA Design Control, ISO 13485, and ISO 14971 compliance, guiding

Qualifications

• PhD or equivalent experience required for senior role.
• —
• “Demonstrated ability to lead cross-functional teams through product development.”

Responsibilities

• Lead design control activities within FDA Design Control framework for class III devices.

Skills

Leadership

Regulatory knowledge

Design Control

PMA/IVD development

Biology knowledge

Education

PhD in Life Sciences, Chemistry, Mathematics, or related field

Master’s degree in Life Sciences, Mathematics, or related field

Bachelor’s degree in Life Sciences, Mathematics, or related field

Tools

Microsoft Office

Excel

PowerPoint

Job description

Abbott Laboratories is seeking a Staff Research Scientist to lead design control activities and manage regulatory submissions for regulated molecular diagnostics products. You will oversee DHF management, design reviews, risk management, and phase-gate governance across the product development lifecycle.

You will collaborate with R&D, Quality, Regulatory Affairs, Clinical Affairs, Manufacturing, and Product Management to ensure FDA Design Control, ISO 13485, and ISO 14971 compliance, guiding