Staff Research Scientist: Molecular Diagnostics Lead

Abbott (abbottcareers2 board); San Diego (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Abbott is a global healthcare leader driving innovation in diagnostics and life sciences. The Staff Research Scientist leads design control, DHF management, risk assessment, and regulatory strategy for regulated molecular diagnostics products across development stages.

In this role you will partner with R&D, Quality, Regulatory Affairs, Clinical Affairs, Manufacturing, and Product Management to ensure adherence to FDA Design Control, ISO 13485, and ISO 14971, delivering robust design history

Qualifications

• Experience with FDA Design Control, ISO 13485, andISO 14971 regulatory standards.
• Proven ability to lead cross-functional product development teams.
• Strong understanding of PMA/IVD molecular diagnostics documentation.

Responsibilities

• Lead product development activities within FDA Design Control for class III devices.
• Own Design and Development Plan creation and updates.
• Manage Design History File (DHF) documentation and design reviews.
• Oversee risk management files and regulatory submission readiness.
• Guide verification, validation, and design transfer activities.
• Collaborate with R&D, Quality, Regulatory Affairs, Clinical Affairs, Manufacturing, and Product Management.
• Represent R&D in cross-functional core teams and design review boards.

Skills

Design Control

Cross-functional

Regulatory

Risk Management

Leadership

Education

Master's or PhD in life sciences or engineering

Job description

Abbott is a global healthcare leader driving innovation in diagnostics and life sciences. The Staff Research Scientist leads design control, DHF management, risk assessment, and regulatory strategy for regulated molecular diagnostics products across development stages.

In this role you will partner with R&D, Quality, Regulatory Affairs, Clinical Affairs, Manufacturing, and Product Management to ensure adherence to FDA Design Control, ISO 13485, and ISO 14971, delivering robust design history