Senior Quality & Regulatory Lead, Medical Devices

Abbott; Alameda (CA); Presencial; USD 140.000 - 170.000; Jornada completa

Descripción de la vacante

Abbott in Alameda, CA seeks a senior Quality & Regulatory professional to lead complex regulatory initiatives ensuring patient safety and compliance. You will prepare MDRs, MedWatch, and Vigilance reports while coordinating with complaint handling, medical affairs, and product quality teams.

Role requires 5+ years in regulated environments, knowledge of 21 CFR Part 11 and ISO 13485, and the ability to drive CAPA and quality system improvements. Travel up to 10% is expected.

Formación

• Bachelor’s degree required or equivalent experience in regulatory, engineering, or life sciences.
• 5+ years in Quality, Compliance, or Engineering within regulated environments (medical devices, diagnostics, or pharma).
• Knowledge of US and international Quality System Requirements and regulatory bodies.
• Familiarity with 21 CFR Part 11 and ISO 13485; consumer regulations a bonus.
• Strong quality engineering foundation and problem-solving skills.

Responsabilidades

• Lead complaint assessments and determine regulatory reportability and impact on patient safety and operations.
• Prepare submissions such as MDRs, MedWatch, and Vigilance reports; liaise with regulators and customers.
• Oversee supplier quality activities including qualification and risk assessment.
• Drive cross-functional quality system improvements and CAPA activities.
• Travel up to 10% domestically/internationally; ensure timely, compliant documentation.

Conocimientos

Regulatory compliance

Quality systems

FDA QSR knowledge

MDR/IVDR expertise

Supplier quality

Regulatory reporting

Cross-functional leadership

Project management

Written regulatory communications

Analytical skills

Educación

Bachelor's degree in life sciences/engineering/regulatory

Herramientas

Regulatory databases

CAPA systems

Excel

Document management systems

Descripción del empleo

Abbott in Alameda, CA seeks a senior Quality & Regulatory professional to lead complex regulatory initiatives ensuring patient safety and compliance. You will prepare MDRs, MedWatch, and Vigilance reports while coordinating with complaint handling, medical affairs, and product quality teams.

Role requires 5+ years in regulated environments, knowledge of 21 CFR Part 11 and ISO 13485, and the ability to drive CAPA and quality system improvements. Travel up to 10% is expected.