C&R Process Expert — Regulatory Excellence & AI Tools

Mass Digital Health; Cambridge (MA); On-site; USD 134,000 - 186,000; Full time

Benefits offered by this job

PTO

401k

HSA

Stock options

Education reimbursement

Job summary

Philips in Cambridge, MA is seeking a Corrections & Removals Expert who will own and govern C&R processes to ensure they are clear, consistent, and aligned with regulatory requirements. You will lead process maps, procedures, and decision points, working with the Capabilities & Strategy Leader to drive continuous improvement and knowledge sharing.

The role requires 5+ years in C&R, field actions, or post-market surveillance within medical device or pharma, with deep knowledge of FDA, EU MDR,

Qualifications

• Bachelor’s or Master’s in a relevant field with strong regulatory knowledge.
• Experience designing, governing, and improving C&R processes with risk-based thinking.
• Familiarity with FDA, EU MDR, Health Canada, and global medical device regulations.

Responsibilities

• Own C&R process framework, maps, procedures, decision points, and roles.
• Identify gaps and drive practical improvements in C&R activities.
• Lead change-intake processes and monitor effectiveness of changes.
• Explore AI and digital tools to boost efficiency and knowledge access.

Skills

Regulatory expertise

C&R governance

Process improvement

Cross-functional collaboration

Regulatory intelligence

Education

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

Tools

Regulatory databases

Job description

Philips in Cambridge, MA is seeking a Corrections & Removals Expert who will own and govern C&R processes to ensure they are clear, consistent, and aligned with regulatory requirements. You will lead process maps, procedures, and decision points, working with the Capabilities & Strategy Leader to drive continuous improvement and knowledge sharing.

The role requires 5+ years in C&R, field actions, or post-market surveillance within medical device or pharma, with deep knowledge of FDA, EU MDR,