C&R Process Expert — Regulatory Excellence & AI Tools

Philips; Cambridge (MA); On-site; USD 134,000 - 186,000; Full time

Benefits offered by this job

Total Rewards benefits

Generous PTO

401k match

HSA contribution

Stock purchase plan

Education reimbursement

Job summary

Philips is seeking a Corrections & Removals Expert in Cambridge, MA. You will own C&R processes, govern compliance with FDA, EU MDR, and global requirements, and drive continuous improvement across the organization. This role emphasizes governance, knowledge sharing, and enabling consistent C&R practices with an AI-enabled mindset.

Office-based, with onsite collaboration at least 3 days per week; requires 5+ years in relevant field and a Bachelor’s/Master’s in Medical Sciences or related area.

Qualifications

• Bachelor's/Master's Degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management or equivalent.
• 5+ years of experience in Pharma, IVD, Medical Device, Quality Assurance, Quality Control, Clinical Research or equivalent.
• Experience with global medical device regulations and standards related to C&R/field actions, including FDA, EU MDR, Health Canada.

Responsibilities

• Serve as SME for C&R processes with regulatory foundations and expectations.
• Apply regulatory mindset to design and evaluate C&R processes for risk-based control and documentation.
• Collaborate on the C&R framework: process maps, procedures, roles, inputs/outputs, tools, and guidance.
• Identify gaps, inconsistencies, and risks; lead improvements.
• Establish and manage a structured approach for C&R change requests with end-to-end governance.
• Identify opportunities to use AI and digital tools to improve C&R efficiency and knowledge access.

Skills

Regulatory knowledge

Process ownership

AI & digital tools

Education

Bachelor's/Master's Degree in Medical Sciences or equivalent

Job description

Philips is seeking a Corrections & Removals Expert in Cambridge, MA. You will own C&R processes, govern compliance with FDA, EU MDR, and global requirements, and drive continuous improvement across the organization. This role emphasizes governance, knowledge sharing, and enabling consistent C&R practices with an AI-enabled mindset.

Office-based, with onsite collaboration at least 3 days per week; requires 5+ years in relevant field and a Bachelor’s/Master’s in Medical Sciences or related area.