Corrections & Removals Expert

About the role

This position is responsible for ensuring that Corrections & Removals (C&R) processes are clear, consistent, effective and compliant with global regulatory requirements. The role focuses on process ownership, governance, continuous improvement and knowledge sharing across the organization.

Key responsibilities

• Serve as subject‑matter expert for C&R processes, applying a regulatory mindset to design and evaluate risk‑based, controlled procedures.
• Collaborate with the C&R Capabilities & Strategy Leader to develop and maintain process maps, procedures, decision points, roles, tools and templates.
• Identify gaps, inconsistencies and risks in existing C&R workflows and lead practical improvement initiatives.
• Manage a structured change‑request process covering intake, assessment, prioritisation, stakeholder review, approval, implementation and effectiveness monitoring.
• Explore AI and digital tools to enhance process efficiency, knowledge management and decision support.

Required profile

• Bachelor’s or Master’s degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management or a related field.
• At least 5 years of experience in pharma, IVD or medical‑device quality assurance/control, with a minimum of 5 years specifically in Corrections & Removals, field actions or post‑market surveillance.
• Demonstrated experience with global medical‑device regulations such as FDA, EU MDR, Health Canada and other applicable standards.

What we offer

• Competitive salary range ($126,000 – $186,000 annually) with potential annual incentive bonus.
• Comprehensive total‑rewards package including generous PTO, 401(k) match up to 7 %, HSA contributions, stock purchase plan and education reimbursement.
• Opportunity to work at a leading health‑technology company committed to improving global access to quality healthcare.