Corrections & Removals Expert

Your role:

In this role you Are responsible for ensuring that C&R processes are clear, consistent, effective, well-governed, and aligned with applicable regulatory requirements. The role is particularly focused on process ownership, governance, continuous improvement, execution, knowledge sharing, and enabling consistent C&R practices across the organization.

Your role:
Serve as a subject matter expert for C&R processes and ways of working, with a strong understanding of the regulatory foundations, requirements, and expectations applicable to corrections and removals.

Apply a regulatory mindset when designing and evaluating C&R processes, considering whether processes are appropriately risk-based, controlled, documented, and capable of meeting regulatory expectations.

Work with the C&R Capabilities & Strategy Leader on the C&R process framework, including process maps, procedures, decision points, roles and responsibilities, inputs and outputs, tools, templates, and supporting guidance.

Identify gaps, inconsistencies, and risks in C&R processes and lead the development and implementation of practical improvements.

Establish and manage a structured approach for C&R process change requests, including intake, assessment, prioritization, stakeholder review, approval, implementation, communication, and effectiveness monitoring.

Identify opportunities to use AI and digital tools to improve C&R process efficiency, knowledge management, consistency, decision support, and access to regulatory and process information.

Bachelor's/Master's Degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management or equivalent.

You’ve acquired 5+ years of experience with Bachelor's in areas such as Pharma, IVD, Medical Device, Quality Assurance, Quality Control, Clinical Research or equivalent.

We prefer a minimum of 5 years In Correction & Removal, Field Action, Post-Market Surveillance.

Experience with global medical device regulations and standards relevant to C&R/field actions, including FDA requirements, EU MDR, Health Canada, and other applicable global requirements.

You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an office role.

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

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The pay range for this position in Bothell, WA is $134,000 to $186,000 Annually. The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan,…