Manager - Post Market Surveillance (Field Action)

Key Responsibilities

• Lead global recalls, product corrections, removals, and field actions.
• Manage HHEs and support risk assessments with Quality, Medical Affairs, and other stakeholders.
• Oversee recall strategies, regulatory submissions, customer communications, and closure activities.
• Serve as the primary liaison with global regulatory agencies and notified bodies.
• Ensure compliance with applicable regulations, quality standards, and internal procedures.
• Monitor recall performance metrics and provide leadership updates.
• Drive continuous improvement of recall processes and operational effectiveness.
• Act as the recall subject matter expert during audits and regulatory inspections.
• Lead, mentor, and develop Recall team members.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Biomedical Sciences, or a related field.
• 4+ years of experience managing recalls, HHEs, and field actions in the medical device and/or pharmaceutical industry.
• 5+ years of experience working within a regulated Quality Management System (QMS).
• Knowledge of FDA regulations (21 CFR Parts 806, 803, 805, and 820), ISO 13485, ISO 14971, and EU MDR.
• Experience preparing recall documentation and interacting with domestic and international regulatory authorities.
• Strong leadership, communication, and project management skills.
• Experience supporting audits and inspections preferred.
• Risk Management experience is a plus.
• Ability to travel up to 10% domestically and internationally.

Pay Rate

Low: $1000.00 | High: $130,000

Work Location

Remote OR Hybrid if in NJ/CT area