Recall Process Lead – Medical Devices & HHE Strategy

CooperSurgical; Trumbull (CT); On-site; USD 107,000 - 150,000; Full time

Benefits offered by this job

401(k)

Parental leave

Paid time off

Job summary

A leading fertility and women’s healthcare company in Trumbull is seeking a Recall Process Owner to lead the assessment and execution of corrections for medical products. This role involves managing documentation and communications during recalls, collaborating with various stakeholders, and ensuring compliance with FDA and global regulations. The ideal candidate has over 4 years of experience in leading recall strategies and possesses a Bachelor's degree in Biomedical Science or Engineering. The position offers a comprehensive benefits package including medical coverage and parental leave.

Qualifications

• 4+ years leading Health Hazard Evaluations and Recall activities.
• Strong ability to influence and communicate with various stakeholders.
• Experience in Risk Management and Quality Management Systems.

Responsibilities

• Lead CSI Recall process and manage internal/external communications.
• Collaborate with quality teams to develop and approve evaluations.
• Ensure compliance with global laws and internal policies.

Skills

Knowledge of FDA regulations

Analytical and presentation skills

Communication with stakeholders

Ability to manage multiple tasks

Understanding Quality Management Systems

Education

Bachelor’s degree in Biomedical Science or Engineering

Tools

e-QMS technology

Job description

A leading fertility and women’s healthcare company in Trumbull is seeking a Recall Process Owner to lead the assessment and execution of corrections for medical products. This role involves managing documentation and communications during recalls, collaborating with various stakeholders, and ensuring compliance with FDA and global regulations. The ideal candidate has over 4 years of experience in leading recall strategies and possesses a Bachelor's degree in Biomedical Science or Engineering. The position offers a comprehensive benefits package including medical coverage and parental leave.