Sr Spec Clinical Product Surveillance

Medline; Mundelein (IL); Vor Ort; USD 92.000 - 138.000; Vollzeit

Benefits dieser Stelle

Health insurance

401(k) contributions

Paid time off

Zusammenfassung

Medline Industries, LP in Mundelein, IL seeks an experienced Clinical Product Surveillance lead to assess complaints, file MDRs, and guide post-market activities. The role mentors the Clinical Product Surveillance team and collaborates with QA and product division to improve patient safety.

Responsibilities include risk analysis, CER support, and training staff on post-market regulations. A Bachelor’s in medical science or health field is required with 6+ years of clinical risk management

Qualifikationen

• Education and experience in clinical risk management or pharmacovigilance.
• Experience with analyzing and reporting data to identify issues and trends.
• Ability to communicate technical information to non-technical audiences and to work with cross-functional teams.

Aufgaben

• 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 QA and product division.
• Review, evaluate and classify potential reportable customer safety complaints.
• Ensure customer communications are created and issued; review responses for technical accuracy.
• Conduct risk analysis and design development modifications for new and existing products; provide clinical insight and risk controls leads.
• Lead the patient safety and risk analysis; assist in CERs for EU CE devices.
• Lead team projects and assignments; provide peer mentoring.

Kenntnisse

Clinical risk management

Data analysis

FDA reporting

Cross-functional teamwork

Communication

Time management

Ausbildung

Bachelor's degree in medical science/health sciences/healthcare field

Bachelor's Degree in Nursing (preferred)

Tools

Microsoft Office

Jobbeschreibung

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.

Job Description

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.

Salary and Benefits

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. For a more comprehensive list of our benefits please click here .

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 oppo