Correction and Removal Specialist

Correction & Removal (C&R) Specialist role focused on ensuring compliance with global medical device regulations, overseeing corrective actions, and managing regulatory documentation and reporting.

Job Requirements:

• Bachelor's degree in a relevant field
• 4-6 years of experience in the medical device, pharmaceutical, or other regulated industry (IVD, Pharma)
• Basic understanding of global medical device regulations such as ISO 13485, FDA QSR, and 21 CFR 806
• Experience in regulatory reporting and compliance

Preferred Skills:

• Knowledge of Field Safety Notices (FSN) and Correction & Removal (C&R) processes
• Experience coordinating with regulatory agencies and internal stakeholders

Job Responsibilities:

Strategic:

• Ensure processes for specifying and executing corrections and removals (C&R) are adequate and aligned with risk management and CAPA
• Maintain oversight of C&R across top management
• Ensure availability of tools for efficient and effective C&R programs

Operational:

• Monitor and coordinate sub-system feeders to the Correction & Removal Review Board (CRRB) to ensure timely input and decisions
• Prepare and manage key documents, including Health Hazard Evaluations, Correction and Removal files, UAL/CAL, regulatory reports, periodic updates, and termination requests
• Track field actions and provide ongoing progress updates to key business partners and regulatory operations teams
• Provide actionable and insightful C&R analytics across the organization

Markets:

• Submit FSN communications to competent authorities and regulatory agencies as required by country or market regulations
• Monitor KPIs and escalate issues to ensure timely closure of corrective actions
• Support resolution of Field Change Order (FCO) prioritization in local markets while ensuring alignment with C&R priorities

Leadership & Compliance:

• Work on issues requiring analysis of data and current business trends
• Act as an advisor to ensure compliance with schedules and technical resolutions
• Develop and administer schedules and performance requirements
• Maintain budget responsibilities related to C&R processes

Pay Details: $36.00 to $48.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.entegee.com/candidate-privacy-information-statement/

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance