Job DescriptionResponsibilities- Leads CSI Recall process for assessment & execution of corrections and removal of a wide variety of medical products (e.g., medical devices, IVDs).
- Responsible for all aspects of CSI's Recall process, including but not limited to preparation of required regulatory documentation and internal/external communications related to Recalls (e.g., Health Hazard Evaluation, Recall Execution Strategy, Field Safety Communications, Recall Termination Requests).
- Manages Health Hazard Evaluations from initiation through completion, leading cross-functional teams through process, ensuring timely completion.
- Collaborates closely with leadership in Quality & Medical Affairs on the development/approval of HHEs.
- Provides direction/guidance to Recall team on execution of Recalls with customers, distributors, and regional RAQA representatives.
- Leads all Recall reporting activities (including 806/FSCA reports) to US FDA, EU Competent Authorities and other Health Authorities globally, as needed. Maintains active communication with CSI's Authorized Representative(s) and Notified Body, as required.
- Ensures reporting requirements are compliant with CSI Policy in accordance with applicable global laws & regulations.
- Collaborates closely with CSI cross-functional leaders across various Business Units & Global Markets.
- Resolves Regulatory Agency/Health Authority requests in relation to reportable Corrections and Removals, ensuring timely closure/termination.
- Maintains and monitors HHE/Recall Key Performance Indicators (KPI), escalating and reporting progress to CSI Leadership on HHEs/Recalls as appropriate/required per local QMS procedures.
- Establishes and maintains department metrics that complement CSI goals, targets, and objectives.
- Assesses and identifies process improvements, developing and implementing business solutions related to Recall process.
- Serves as CSI's Recall Process Owner and Subject Matter Expert, leading all front room Recall interactions during Notified Body MDSAP audits/FDA inspections.
- Ensure Recall procedures and processes are compliant with all applicable global regulations.
- Stays apprised of latest developments in the global regulatory landscape related to Recalls.
- Manages, develops and mentors Recall team, creating an atmosphere of encouragement, motivation, and growth opportunity.
- Performs other duties as assigned.
Travel:This position may require 0-10% domestic and/or foreign travel.
QualificationsKnowledge, Skills and Abilities:- Knowledge and ability to lead Recalls from initiation to closure in a medical device or pharmaceutical organization.
- Excellent analytical, written and verbal skills, including strong presentation skills.
- Ability to communicate with and influence various stakeholders at all organizational levels.
- Ability to balance multiple projects/tasks, with a high degree of initiative and flexibility to adapt in changing environments.
- Expert knowledge of FDA regulation 21 CFR 806, working knowledge of 21 CFR 803, 805, 806, 820 and ISO standards 13485, 14971, and EU MDR 2017/745, MDCG 2023-3.
- Understanding of Quality Management Systems and the associated interrelationship with Recall process.
- Ability to work efficiently in an e-QMS and incorporate technology (e.g., Artificial Intelligence tools) into the Recall process.
- Ability to work within a global organization/team.
Work Environment:- Prolonged periods of sitting, especially in front of a computer.
Experience:- 4+ years leading HHEs and Recall decisions/Recall strategy.
- Experience writing Recall communications.
- Experience presenting as Recall owner in audits/inspections.
- 5+ years of Quality Management Systems experience.
- Experience in Risk Management preferred.
Education:- Bachelor's degree in Biomedical Science, Engineering or a related field.
As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.
For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $107,000 - $150,000. The actual base pay includes many factors, and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.
