Corrections & Removals Expert

Mass Digital Health

Cambridge (MA)

On-site

USD 134,000 - 186,000

Full time

6 days ago
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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

Job Title

Corrections & Removals Expert

Job Description

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.

You're the right fit if:

  • 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.
How we work together

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.

About Philips

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.

  • Learn more about our business.
  • Discover our rich and exciting history.
  • Learn more about our purpose.
  • Learn more about our culture.
Philips Transparency Details

The pay range for this position in Cambridge MA 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, education reimbursement and much more. Details about our benefits can be found here.

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

Additional Information

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Cambridge MA.

#LI-PHI

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.

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