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Manager- Post Market Surveillance (Recall)

CooperSurgical · Livingston, NJ · 3 mo ago
RemoteRemoteBusiness Development$107k–$150k/yrFull-time

About the role

The Manager, Post Market Surveillance- Recall is responsible for CooperSurgical, Inc.’s (CSI) global Post Market Surveillance Recall activities, working with various internal and external stakeholders, and managing the Recall team. This position oversees all aspects of CSI’s global Recall process, including preparation of Health Hazard Evaluations (HHEs), executing Corrections and Removals, interacting with regulatory authorities, and identifying continuous improvement opportunities.

Responsibilities

  • Leads CSI Recall process for assessment and execution of corrections and removal of a wide variety of medical products (e.g., medical devices, IVDs).
  • Manages all aspects of CSI’s Recall process, including 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 to ensure timely completion.
  • Collaborates closely with leadership in Quality & Medical Affairs on the development and approval of HHEs.
  • Provides direction and guidance to the 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 global Health Authorities 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 and regulations.
  • Collaborates with CSI cross-functional leaders across various Business Units and Global Markets.
  • Resolves Regulatory Agency/Health Authority requests related to reportable Corrections and Removals, ensuring timely closure and termination.
  • Maintains and monitors HHE/Recall Key Performance Indicators (KPI), escalating and reporting progress to CSI Leadership as appropriate.
  • Establishes and maintains department metrics that complement CSI goals, targets, and objectives.
  • Assesses and identifies process improvements, developing and implementing business solutions related to the Recall process.
  • Serves as CSI’s Recall Process Owner and Subject Matter Expert, leading all front-room Recall interactions during Notified Body MDSAP audits and FDA inspections.
  • Ensures Recall procedures and processes are compliant with all applicable global regulations.
  • Stays apprised of the latest developments in the global regulatory landscape related to Recalls.
  • Manages, develops, and mentors the Recall team, fostering 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.

Requirements

  • 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.

Qualifications

  • 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 their interrelationship with the 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.

Education: Bachelor’s degree in Biomedical Science, Engineering, or a related field preferred.

Benefits

  • Great compensation package, including medical coverage and 401(k).
  • Parental leave and fertility benefits.
  • Paid time off for vacation, personal, sick, and holidays.
  • Multiple other perks and benefits.

Pay

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.

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