Spec Clinical Product Surveillance

Medline Industries, LP • Mundelein, IL

2d • $79,000 - $119,000

About The Position

Under general supervision, the Clinical Product Surveillance Specialist independently applies knowledge of clinical workflows and product use to investigate post-market complaints and provide clinical resource support to internal and external customers. The role serves as a patient safety advocate and participates in cross-functional activities involving complaint handling, risk management, design quality, and regulatory compliance to support product safety and efficacy and recommend improvements or corrections.

The specialist investigates potential safety issues, processes and coordinates adverse-event reporting, evaluates clinical and safety risks, and supports post-market surveillance and product development or modification. The position also contributes to regulatory compliance, audits, process improvements, procedures, training, and customer communications, while maintaining active RN licensure in good standing.

Requirements

• Bachelor's degree in Nursing (BSN).
• Active RN license to administer healthcare, in good standing with the state or other governing licensure body.
• 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.
• 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, including Outlook, Teams, Excel, Word, and PowerPoint.
• Strong work ethic and proactive approach to responsibilities.
• Customer-focused, results-oriented mindset.
• Ability to make sound judgments while prioritizing patient safety.
• Teamwork, 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 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.

Nice To Haves

• Advanced degree in nursing, medical or healthcare sciences, or another healthcare-related field.
• Healthcare license, registration, or certification from a state or other governing body; specialty nursing certification (such as APRN, CNS, CEN, or CCRN) or certification in another healthcare-related field.
• Experience in a Perioperative/OR or Critical Care setting, such as an Emergency Department, ICU, Step-Down ICU, or Cath Lab.
• Experience in clinical, medical device, or pharmaceutical risk management, or within the medical device or pharmaceutical industry.
• Experience or working knowledge of government and industry standards and regulations for medical products, such as 21 CFR 803, 21 CFR 314, 21 USC 379aa, 21 CFR 7, ISO 13485, and ISO 14971.
• Understanding of the clinical environment and product workflow.
• Familiarity with medical device application as it relates to patient safety.

Responsibilities

• Identify and investigate domestic and international post-market complaints with potential safety issues, escalating complaints for further investigation when needed.
• Ensure adverse event reports, including MDRs and ICSRs, are processed, prepared, and submitted to the FDA within regulatory timelines.
• Process FDA-reportable post-market complaints and help coordinate international adverse event reporting with local health authorities or authorized representatives.
• Collaborate with team members and serve as a clinical resource for internal and external customers.
• Ensure communications are created and issued to internal and external customers, and 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 or modification processes for new and existing products.
• Participate in analysis of safety and risk data, identifying 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 and participate in regulatory audits, communications with regulatory bodies, and additional-information requests as applicable.
• Participate in process improvements and Corrective and Preventative Actions (CAPAs).
• Participate in development and maintenance of adverse-event reporting and risk-management processes, and Standard Operating Procedures 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 licensure in good standing with the state or other governing licensure body.

Benefits

• Competitive total rewards package.
• Continuing education and training.
• Health insurance for employees working an average of 30 or more hours per week.
• Life and disability coverage for employees working an average of 30 or more hours per week.
• 401(k) contributions.
• Paid time off.
• For employees working less than 30 hours per week, access to the Employee Assistance Program, Employee Resource Groups, and the Employee Service Corp.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level