Combination Product Analyst IV – Quality Assurance

About the role

The Combination Product Analyst IV will lead high‑volume end‑to‑end complaint handling and Medical Device Reporting (MDR) activities for combination products, ensuring regulatory compliance and driving process improvements across global sites.

Key responsibilities

• Intake, triage, and review of product quality complaints, determine MDR reportability, and coordinate field sample evaluation.
• Perform risk assessments, trend analysis, defect coding, and ensure timely QP notifications.
• Provide guidance on complaint and MDR documentation, support audits, and act as a subject‑matter expert for regulatory inquiries.
• Lead root‑cause investigations, corrective actions, and SOP/Work Instruction updates using Process Excellence tools.
• Collaborate with Global Medical Safety, manufacturing sites, IT, and external partners to improve complaint handling efficiency.

Required profile

• 5+ years of experience in Quality Assurance/Control within pharmaceutical, medical device, or similarly regulated industry.
• Strong organizational and project‑leadership skills with a global mindset.
• Ability to communicate effectively with senior management and cross‑functional teams.

Required skills

• Knowledge of 21 CFR parts 4, 820, 803, 806, 210, 211, 314, ICH Q10, GMP, GVP, GDP.
• Familiarity with ISO 13485, ISO 14971, MEDEV 2.12, CMDR, and Medical Device Directive 93/42/EEC.
• Experience with risk assessment, root‑cause analysis, process mapping, and statistical data‑driven decision making.
• Proficiency in regulatory reporting and complaint management systems.