Corrections & Removals Expert

Jobgether

United States

On-site

USD 134,000 - 186,000

Full time

3 days ago
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Benefits offered by this job

Health insurance
401(k) matching
HSA with company contribution
Stock purchase plan
Education reimbursement
Paid time off
Professional development

Job summary

Jobgether via partner company seeks a Corrections & Removals Expert in the United States to strengthen C&R processes across a global healthcare environment. You will design, govern, and improve processes, ensure alignment with regulatory expectations, and collaborate with capability leaders and cross-functional teams.

The role blends process ownership, risk management, and knowledge management, with opportunities to apply AI and digital tools to improve decision support, efficiency, and

Qualifications

  • Bachelor’s or Master’s degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management, or an equivalent discipline.
  • At least 5 years of professional experience in related fields with a Bachelor’s degree.
  • 5+ years specifically in Corrections and Removals, Field Actions, Post-Market Surveillance or similar responsibilities.

Responsibilities

  • Serve as SME for corrections and removals processes with regulatory foundations and expectations.
  • Design, evaluate, and improve C&R processes with risk-based thinking and documentation.
  • Develop and maintain process framework including maps, procedures, and roles.
  • Identify gaps and lead practical improvements for C&R processes.
  • Establish structured change-management for C&R requests and monitoring.
  • Promote knowledge sharing and consistent adoption of C&R practices.
  • Explore AI and digital technologies to improve C&R efficiency and knowledge access.

Skills

Regulatory thinking
Process ownership
Risk assessment
Analytical skills
Cross-functional collaboration
Communication skills
AI tools familiarity

Education

Medical Sciences / Healthcare degree

Tools

Regulatory software
Quality management tools

Job description

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Corrections & Removals Expert based in United States.

This role serves as a subject matter expert responsible for strengthening corrections and removals (C&R) processes across a global healthcare environment. You will help ensure that processes are clear, consistent, effective, well-governed, and aligned with applicable regulatory expectations. The position combines process ownership, regulatory thinking, continuous improvement, execution, and knowledge management. You will work closely with capability and strategy leaders and cross-functional stakeholders to identify risks, gaps, and opportunities for improvement. Your expertise will help establish consistent practices and strengthen the organization’s ability to manage complex C&R activities. The role also provides an opportunity to explore AI and digital tools that can improve efficiency, decision support, and access to critical regulatory and process information.

Accountabilities
  • Serve as a subject matter expert for corrections and removals processes and ways of working, applying a strong understanding of regulatory foundations, requirements, and expectations relevant to field actions and post-market activities.
  • Apply a regulatory and risk-based mindset when designing, evaluating, and improving C&R processes, ensuring that activities are appropriately controlled, documented, and capable of meeting applicable regulatory expectations.
  • Partner with C&R capability and strategy leadership to develop and maintain the process framework, including process maps, procedures, decision points, roles and responsibilities, inputs, outputs, tools, templates, and supporting guidance.
  • Identify process gaps, inconsistencies, control weaknesses, and operational risks, and lead the development and implementation of practical improvements.
  • Establish and manage a structured process for C&R change requests, covering intake, assessment, prioritization, stakeholder review, approval, implementation, communication, and effectiveness monitoring.
  • Support knowledge sharing and consistent adoption of C&R practices across the organization by helping stakeholders understand processes, requirements, and appropriate ways of working.
  • Identify and evaluate opportunities to use AI and digital technologies to improve C&R efficiency, knowledge management, process consistency, decision support, and access to regulatory and procedural information.
Requirements
  • Bachelor’s or Master’s degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management, or an equivalent discipline.
  • At least 5 years of professional experience with a Bachelor’s degree in areas such as pharmaceuticals, in-vitro diagnostics, medical devices, quality assurance, quality control, clinical research, or a related field.
  • A minimum of 5 years of experience specifically involving Corrections and Removals, Field Actions, Post-Market Surveillance, or closely related responsibilities is preferred.
  • Strong knowledge of global medical device regulations and standards relevant to corrections and removals and field actions, including FDA requirements, EU MDR, Health Canada requirements, and other applicable international regulations.
  • Demonstrated ability to assess processes from a regulatory, risk-management, governance, and continuous-improvement perspective.
  • Strong analytical and problem-solving skills, with the ability to identify gaps, assess risks, prioritize improvements, and translate regulatory expectations into practical processes.
  • Excellent collaboration and communication skills, with the ability to work effectively across functions and within a complex, matrixed organization.
  • Ability to manage multiple stakeholders, communicate process changes clearly, and support consistent adoption of new ways of working.
  • Comfortable working with digital tools and exploring emerging technologies, including AI, to improve operational efficiency and knowledge management.
  • Must be legally authorized to work in the United States without requiring current or future visa sponsorship.
  • Must be able to successfully meet the applicable physical, cognitive, and environmental requirements of an office-based position, with reasonable accommodation where applicable.
  • This is an office-based role requiring residence in or within commuting distance of Cambridge, Massachusetts.
Benefits
  • Annual base salary range of $134,000–$186,000 USD, with the actual offer determined by factors including qualifications, experience, business needs, geographic location, and internal equity.
  • Potential eligibility for additional compensation, including an annual incentive bonus or other long-term incentive opportunities.
  • Comprehensive healthcare benefits, including medical, dental, and vision coverage.
  • Generous paid time off.
  • 401(k) retirement plan with up to a 7% company match.
  • Health Savings Account (HSA) with company contribution.
  • Employee stock purchase plan.
  • Education reimbursement to support ongoing professional development.
  • Opportunities to work on complex regulatory and healthcare initiatives with broad organizational impact.
  • Professional development and career growth opportunities in a collaborative, purpose-driven environment.
  • Office-based work in Cambridge, Massachusetts, with no relocation assistance provided.
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