Spec Clinical Product Surveillance

Job description

Job Summary Under general supervision, the Clinical Product Surveillance Specialist is responsible for independently using knowledge of clinical workflows and product use when investigating post-market complaints and providing clinical resource support to internal and external customers. This role acts as a patient safety advocate and participates in various cross-functional activities that include, but are not limited to, Complaint Handling, Risk Management, Design Quality, and Regulatory Compliance, to support product safety and efficacy and recommend improvements and/or corrections as needed. Job Description: Responsibilities: Identify and investigate domestic and international post-market complaints with a potential safety issue and escalate complaints for further investigations as needed Ensure adverse event reports (i.e., MDRs, ICSRs) are processed, prepared, and submitted to the FDA within regulatory timelines. Process FDA reportable post-market complaints and assist in coordinating international adverse event reporting with local health authorities or authorized representatives. Collaborate with team members and act as a clinical resource for internal and external customers...