Spec Clinical Product Surveillance

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.

• Ensure communications are created and issued to internal and external customers. Review customer responses for technical and clinical accuracy as related to Medline products.

• Provide clinical insight, evaluation, and resolution during post-market, risk management, and design development/modifications processes for new and existing Medline products.

• Participate in the analysis of safety and risk data within areas of responsibility and identify actionable findings, trends, or product safety issues that require further investigation.

• Assess clinical, health, and safety risks during Health Hazard Evaluations, product recall or field action determinations, and acceptance of product as-is.

• Ensure compliance with applicable post-market regulations for areas of responsibility and participate in regulatory audits, regulatory body communications, and/or additional information requests as applicable.

• Participate in process improvements and Corrective and Preventive Actions (CAPAs).

• Participate in the development and maintenance of processes/procedures associated with Adverse Event Reporting, Risk Management, and Standard Operating Procedures (SOPs) associated with Clinical Risk Evaluation.

• Facilitate clinical safety meetings and conduct training related to post-market surveillance, clinical use, product risk, and SOP requirements.

• Maintain active Registered Nurse (RN) licensure and good standing with the state or other governing licensure body.

• Actively licensed as an RN to administer healthcare and in good standing with the state or other governing licensure body.

Education

Bachelor's Degree in Nursing (BSN) with at least 5 years of patient care experience OR a BSN with 4 years or less of patient care experience and 2 years of experience in a similar role.

Skills

• Knowledge of quality improvement and patient safety.

• Understanding of clinical standards, processes, and workflows.

• Familiarity with medical devices and pharmaceuticals related to patient safety.

• Ability to assess clinical outcomes, analyze data, and present findings to various audiences.

• Proficiency in Microsoft Office (Outlook, Teams, Excel, Word, PowerPoint).

• Strong work ethic and proactive approach to responsibilities.

• Customer-focused with a results-oriented mindset.

• Ability to make sound judgments prioritizing patient safety.

• Team player with analytical skills and a positive attitude.

• Experience in data analysis and reporting to identify trends and solutions.

• Experience working with cross-functional teams to solve complex problems.

• Effective time management skills to handle multiple projects and deadlines.

• Ability to work independently and escalate issues when necessary.

• Problem-solving skills to overcome obstacles and find successful solutions.

• Advanced degree in nursing, medical or healthcare sciences, or other healthcare-related field.

Certifications

• Licensed, registered, or certified by a state or other governing body to administer health care. Certification in a nursing specialty (i.e. APRN, CNS, CEN, CCRN, etc.) or other healthcare-related field.

• Experience within a Perioperative/OR or Critical Care (i.e. Emergency Department, ICU, Step-Down ICU, Cath Lab, etc.) setting.

• Experience in