Product Surveillance Associate I

CooperCompanies•North Tonawanda, NY

20h•Onsite

About The Position

CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com. Work location: North Tonawanda, NY; Trumbull, CT; or Livingston, NJ (on-site). The Product Surveillance Associate I supports post market surveillance activities for combination drug‑device products in compliance with applicable U.S. and international regulatory requirements, including 21 CFR Parts 210, 211, 820, and ISO 13485. This role focuses on the execution, documentation, and support of product complaint investigations and post market surveillance activities to help ensure product safety, performance, quality, and regulatory compliance throughout the product lifecycle, and works cross‑functionally with team members, Product Surveillance Engineers, and Quality leadership to identify potential risks, support appropriate escalation and remediation activities, and maintain accurate, inspection‑ready records that support the organization’s Quality Management System and regulatory obligations. The Product Surveillance Associate I is responsible for performing, documenting, and supporting timely and compliant product complaint investigations for combination drug‑device products. This position evaluates post market information to support assessments of product performance, patient safety, and regulatory impact, and assists in determining whether escalation activities such as CAPA initiation, Health Hazard Evaluations, trending, or regulatory reporting may be required, and partners with Quality, Regulatory Affairs, R&D, Manufacturing, Medical Affairs, and Supply Chain to support root cause analysis activities, follow‑up actions, and verification of corrective actions under defined procedures and supervision. This role helps ensure post market surveillance and complaint records are accurate, complete, and compliant, and supports internal and external audits while contributing to the continuous improvement of post market surveillance and Quality Management System processes.

Requirements

Compliance with applicable U.S. and international regulatory requirements, including 21 CFR Parts 210, 211, 820, and ISO 13485.
Execution, documentation, and support of product complaint investigations.
Execution, documentation, and support of post market surveillance activities.
Identification of potential risks.
Support of appropriate escalation and remediation activities.
Maintenance of accurate, inspection-ready records.
Support of the organization’s Quality Management System and regulatory obligations.
Performing, documenting, and supporting timely and compliant product complaint investigations for combination drug-device products.
Evaluating post market information to support assessments of product performance, patient safety, and regulatory impact.
Assisting in determining whether escalation activities such as CAPA initiation, Health Hazard Evaluations, trending, or regulatory reporting may be required.
Partnering with Quality, Regulatory Affairs, R&D, Manufacturing, Medical Affairs, and Supply Chain to support root cause analysis activities, follow-up actions, and verification of corrective actions under defined procedures and supervision.
Ensuring post market surveillance and complaint records are accurate, complete, and compliant.
Supporting internal and external audits.
Contributing to the continuous improvement of post market surveillance and Quality Management System processes.

Responsibilities

Supports post market surveillance activities for combination drug‑device products in compliance with applicable U.S. and international regulatory requirements, including 21 CFR Parts 210, 211, 820, and ISO 13485.
Focuses on the execution, documentation, and support of product complaint investigations and post market surveillance activities to help ensure product safety, performance, quality, and regulatory compliance throughout the product lifecycle.
Works cross‑functionally with team members, Product Surveillance Engineers, and Quality leadership to identify potential risks, support appropriate escalation and remediation activities, and maintain accurate, inspection‑ready records that support the organization’s Quality Management System and regulatory obligations.
Performs, documents, and supports timely and compliant product complaint investigations for combination drug‑device products.
Evaluates post market information to support assessments of product performance, patient safety, and regulatory impact.
Assists in determining whether escalation activities such as CAPA initiation, Health Hazard Evaluations, trending, or regulatory reporting may be required.
Partners with Quality, Regulatory Affairs, R&D, Manufacturing, Medical Affairs, and Supply Chain to support root cause analysis activities, follow‑up actions, and verification of corrective actions under defined procedures and supervision.
Helps ensure post market surveillance and complaint records are accurate, complete, and compliant.
Supports internal and external audits while contributing to the continuous improvement of post market surveillance and Quality Management System processes.

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