Manager, Post Market Surveillance (Recall)

About the role

CooperSurgical is seeking a Manager to lead its Post Market Surveillance (Recall) activities. This role ensures that medical device recalls are managed efficiently, protecting patient safety and complying with regulatory requirements.

Key responsibilities

• Develop and execute recall strategies for medical devices across the United States.
• Coordinate with cross‑functional teams, including regulatory, quality, and clinical affairs, to gather and assess field data.
• Lead investigations, root‑cause analyses, and corrective actions for recalled products.
• Maintain comprehensive documentation and reporting to FDA and other regulatory bodies.
• Communicate recall status and actions to internal stakeholders and external partners.

Required profile

• Proven experience in post‑market surveillance, recall management, or related regulatory functions within the medical device industry.
• Strong understanding of FDA regulations and international standards governing device recalls.
• Excellent analytical, problem‑solving, and decision‑making abilities.
• Effective communication skills for interacting with senior leadership and external agencies.

Required skills

What we offer

• Competitive compensation and benefits package.
• Opportunities to work on innovative fertility and women’s health technologies.
• Supportive, collaborative work environment.