Sr Spec Clinical Product Surveillance

Medline Industries, Inc. in; Mundelein (IL); On-site; USD 92,000 - 138,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP seeks a seasoned professional to lead post-market surveillance and risk management for medical device and pharmaceutical products. You will evaluate complaints, prepare regulatory reports, and provide clinical support to QA, product divisions, and sales teams.

You will mentor the Clinical Product Surveillance team, oversee risk analysis, and help develop reporting procedures to ensure compliance with FDA and international health authorities.

Qualifications

• Bachelor's degree in medical sciences or healthcare field plus 4+ years clinical risk management experience.
• Healthcare provider certificate/licensure.
• 6+ years clinical, medical device risk management experience.
• Experience analyzing data to identify issues and drive improvements.
• Ability to communicate technical information to non-technical audiences.
• Experience with cross-functional teams and project coordination.
• Strong time management and ability to handle multiple projects.
• Proficiency with Microsoft Office.

Responsibilities

• Identify complaints affecting patient safety and evaluate them.
• Prepare and submit MDRs and adverse event reports to the FDA.
• Coordinate international reports with local health authorities.
• Collaborate with QA and product division as a clinical resource.
• Lead patient safety and risk analysis activities.
• Develop procedures for MDR and adverse event reporting.
• Conduct trainings on post-market surveillance and SOP requirements.
• Mentor the Clinical Product Surveillance team.

Skills

Data analysis

Technical communication

Cross-functional teamwork

Time management

Self-motivation

Microsoft Office

Education

Bachelor's degree in medical sciences or healthcare

Healthcare provider certificate/licensure

Bachelor’s Degree in Nursing

Tools

Microsoft Office

Job description

Job Summary

Under minimal supervision, use knowledge of clinical workflow and product use in assessing incoming complaints and hazards. Assist in post-market reportability determination.

Leads clinical investigations for reported product incidents and submit adverse event reports.

Provides clinical resource support to customers, sales reps and the product division for clinical issues. Identify hazardous situations from product design, product/material assessments, and customer complaints.

Responsible for mentoring and coaching the Clinical Product Surveillance team.

MAJOR RESPONSIBILITIES

• Identify and evaluate complaints which affect patient safety.
• Prepare and submit Medical Device Reports (MDRs) and drug adverse event reports to the FDA.
• Process MDRs and coordinate international report filing with local health authorities.
• Ensure reportable complaints are processed and submitted.
• Collaborate with team members; act as a clinical resource to QA and product division.
• Review, evaluate and classify potential reportable customer safety complaints.
• Ensure customer communications are created and issued; review customer responses for technical accuracy related to Medline products.
• Conduct risk analysis and design development modifications for new and existing products; provide clinical insight, review, and risk controls leads.
• Assist in CERs for EU/CE marked devices.
• Lead the patient safety and risk analysis.
• Ensure compliance with applicable post-market regulations.
• Identify product safety issues; triage complaints for further investigation.
• Develop and maintain procedures for MDR/ Adverse Event Reporting for medical device, drug, FDA regulated products and international products.
• Perform, review, and write HHE product recall assessments.
• Conduct trainings related to Post-market surveillance, clinical use, product risk, and SOP requirements.
• Compose and submit AI response letters to FDA.
• Lead team projects and assignments; provides peer mentoring and expertise for new team members.

MINIMUM JOB REQUIREMENTS

• Education: Bachelor's degree in medical science, health sciences or healthcare related field and at least 4 years of clinical, medical device risk management, or pharmaceutical risk management experience OR Healthcare provider certificate/licensure.
• Certification / Licensure: None
• Work Experience: at least 6 years of clinical, medical device risk management, or pharmaceutical risk management experience.
• Knowledge / Skills / Abilities: Experience with analyzing and reporting data in order to identify issues, trends, or exceptions to drive improvement of results and find solutions.
• Experience communicating technical information to non-technical audiences.
• Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems.
• Experience using time management skills such as prioritizing/organizing and tracking details and meeting deadlines of multiple projects with varying completion dates.
• Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives and determining when escalation of issues is necessary.
• Experience with Microsoft Office.

PREFERRED JOB REQUIREMENTS

• Education: Bachelor’s Degree in Nursing.
• Certification / Licensure: Licensed, registered, or certified by a state or other governing body to administer health care.
• Work Experience: Experience applying knowledge of FDA and international Health Authority reporting requirements.
• Knowledge / Skills / Abilities: 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: $92,000.00 - $138,000.00 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 roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.

We're dedicated to creating a Medline where everyone feels they belong and can grow their career.

We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best.

Explore our Belonging page here.

Medline Industries, LP is an equal opportunity employer.

Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

Through our culture of belonging, our agile and resilient global team is determined to get our customers exactly what they need, at the right time, every time.

If you're a self-starter, eager to grow your career within a high-performing environment, this is the place for you.

Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care.

Through its broad product portfolio, resilient supply chain and leading clinical solutions, Medline helps healthcare providers improve their clinical, financial and operational outcomes.

Headquartered in Northfield, Illinois, the company employs more than 43,000 people worldwide and operates in more than 100 countries and territories.

To learn more about how Medline makes healthcare run better, visit www.medline.com.