Senior Quality & Regulatory Specialist

Abbott Laboratories; Alameda (CA); On-site; USD 90,000 - 180,000; Full time

Benefits offered by this job

Free medical coverage

Excellent retirement plan

Tuition reimbursement

Education programs

Job summary

Abbott Laboratories in Alameda, CA is seeking a Sr. Quality Specialist to lead complex quality and regulatory initiatives that impact patient safety and business operations.

You will own complaint assessments, regulatory reporting decisions, and submissions such as MDRs, MedWatch, and Vigilance, partnering with cross-functional teams to drive improvements. The role requires strong knowledge of ISO 13485, FDA QSR, and 21 CFR Part 11, plus experience in supplier quality and CAPA processes.

Qualifications

• Bachelor’s degree or equivalent required.
• 5+ years inQuality/Regulatory within medical devices or pharma.
• Knowledge of US/Non-US quality systems and 21 CFR Part 11.
• Experience with MDR/IVDR, ISO 13485 and CAPA processes.

Responsibilities

• Lead complex quality and regulatory initiatives affecting safety and operations.
• Assess complaints, decide regulatory reporting, prepare MDRs/MedWatch/Vigilance.
• Collaborate across complaint handling, customer service, and clinical teams.
• Manage supplier quality activities, qualification and risk assessment.

Skills

Quality Systems

Regulatory Knowledge

ISO 13485

FDA QSR

21 CFR Part 11

Cross-functional Lead

Problem Solving

Education

Bachelor’s Degree or equivalent

Job description

Abbott Laboratories in Alameda, CA is seeking a Sr. Quality Specialist to lead complex quality and regulatory initiatives that impact patient safety and business operations.

You will own complaint assessments, regulatory reporting decisions, and submissions such as MDRs, MedWatch, and Vigilance, partnering with cross-functional teams to drive improvements. The role requires strong knowledge of ISO 13485, FDA QSR, and 21 CFR Part 11, plus experience in supplier quality and CAPA processes.