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

MAJOR 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 regulation 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 investigations.
• 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 Preventative 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 trainings related to post-market surveillance, clinical use, product risk, and SOP requirements.
• Maintain active Registered Nurse (RN) licensure and good standing with state or other governing licensure body.

MINIMUM JOB REQUIREMENTS:

Education:

• Bachelor's Degree in Nursing (BSN)

Certification / Licensure:

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

Work Experience:

• 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 / Skills / Abilities:

• 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.

PREFERRED JOB REQUIREMENTS:

Education:

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

Certification / Licensure:

• 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.

Work Experience:

• Experience within a Perioperative/OR or Critical Care (i.e. Emergency Department, ICU, Step-Down ICU, Cath Lab, etc.) setting.
• Experience in clinical, medical device, or pharmaceutical risk management and/or within the medical device or pharmaceutical industry.
• Experience or working knowledge of government and industry standards and regulations for medical products (i.e. 21 CFR 803, 21 CFR 314, 21 USC 379aa, 21 CFR 7, ISO 13485, ISO 14971, etc.).

Knowledge / Skills / Abilities:

• Understanding of the clinical environment and product work flow.

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