Analyst I, Global Complaint Mgmt & Safety Reg Reporting
ICU Medical, Inc.

Job Info

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Job Description

Position Summary
The position is responsible for managing medical device or pharmaceutical complaints and adverse events globally. This includes the identification, evaluation, documentation, and reporting of incidents that may be subject to global regulatory requirements for the manufacturer, distributor, and the importer of medical devices.

Essential Duties & Responsibilities

• Reviews incidents to determine if a product complaint meets the reporting criteria globally.
• Conducts follow-up activities necessary to make a reportability decision including communication with complaint analysts, quality engineers and obtaining medical evaluations.
• Documents the reporting decision including proper rationale.
• Completes and files regulatory reports, within specified time frames, as applicable for impacted region.
• Monitors department mailbox and triages emails received each day.
• Completes daily assignments in addition to other required regulatory tasks.
• Ensures timely, adequate communication with complaint analysts and investigation teams.
• Responsible for escalating safety issues to management as they occur.
• Works independently and is accountable for completing tasks as assigned. Works well within in a team to accomplish team goals.

Knowledge Skills & Qualifications

• Experience with or knowledge of medical terminology and how medical/pharmaceutical products are typically used in a clinical setting.
• Basic computer and software skills.
• Must be able to communicate effectively with internal and external customers.
• Demonstrate ability to collect, analyze and interpret complaint and adverse event information.

Education and Experience

• Required: Bachelor of Science Degree in Nursing, Bio-Medical Engineering, Pharmacy, Medical Technology/ Clinical Laboratory Science, or other scientific field.
• Preferred: Minimum 1 year of experience in a health care environment, and/or within a quality/compliance/regulatory organization in an FDA regulated business or Pharmacovigilance.

Minimum Qualifications

• Must be at least 18 years of age

Travel Requirements

• Typically requires travel 0-10% of the time

Physical Requirements and Work Environment

• This is largely a sedentary role.
• This job operates in a professional office environment and routinely uses standard office equipment.

About Us

ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges.

With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings.

We're ready to bring you consistent quality, innovation, and value in more areas than ever. Our focus allows us to bring you:

• Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
• The industry's broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.
• IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.
• Significant US IV solutions manufacturing and supply capabilities.

ICU Medical EEO Statement:

ICU Medical is committed to fostering a diverse, inclusive, and equitable work environment. As an Affirmative Action and Equal Opportunity Employer, we ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender identity, gender expression, gender reassignment, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.

If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at humanresources@icumed.com. We are committed to providing equal access and opportunities for all candidates.

ICU Medical EEO Policy Statement

OFCCP Equal Opportunity Posters

"Know Your Rights" Poster
Pay Transparency Nondiscrimination Provision

ICU Medical CCPA Notice to Job Applicants

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