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 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.
Collaborate with team members; act as a clinical resource to QA and product division.
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

Qualifications:

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

Advanced degree in nursing, medical or healthcare sciences, or other healthcare related field.
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 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.).
Understanding of the clinical environment and product work flow. Familiarity with the application of medical device as it relates to patient safety.

Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.

The anticipated salary range for this position:

$79,560.00 - $115,440.00 Annual

The actual salary will vary based on applicant's location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.

Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click here. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.

Every day, we're focused on building a more diverse and inclusive company, one that recognizes, values and respects the differences we all bring to the workplace. From doing what's right to delivering business results, together, we're better. Explore our Diversity, Equity and Inclusion page here.

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.