Corrections & Removals Expert in New York at Jobgether
Explore Related Opportunities
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.
- 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.
- 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.
- 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.