Post Market Surveillance Specialist

Requisition ID 2024-14659

Posting Date 21 hours ago (5/30/2024 8:41 PM)

Job Location(s) Bloomington IN United States

Position Type Full Time

Company Cook Inc - Bloomington

Category Regulatory Affairs

Overview

The Specialist Post Market Surveillance Specialist (PMS) is to support the reporting process, assuring compliance with national and international regulations. Monitors the performance of a medical device after release to the market. Ensures PMS plans and reports are consistent with applicable regulations, standards, and established procedures.

Responsibilities

• Collaborate with functional teams to collect, review, and analyze data for the Post Market Surveillance (PMS) process.
• Schedule and facilitate PMS meetings to discuss plans and reports.
• Collect, review, and edit PMS data for Clinical Evaluation Reports.
• Generate plans and reports to ensure compliance with evolving regulations.
• Monitor, track, and communicate project progress to leadership.
• Ability to prioritize workload and meet project deadlines.
• Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.

• Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.

• Must work and interact effectively and professionally with and for others throughout various levels of the global organization.

• Must strictly adhere to safety requirements.
• Maintain regular and punctual attendance.
• Must maintain company quality and quantity standards.
• Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with minimal supervision.
• Ability to remain calm and receptive in fast paced situations.

Qualifications

Minimum Work Experience/Educational Requirements

• Bachelor's degree required, preferred related field.
• Minimum 1 year experience in the field of Post Market Surveillance in the medical device industry preferred.
• Must be proficient with Microsoft Word, Excel and PowerPoint.

Physical Requirements/Work Environment

• Works under general office environment conditions.
• Utilizes close visual acuity for working with computers and equipment.

• Frequently required to sit, stand, walk, and communicate.

• Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA

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"We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class."

Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state/province and local law.

Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity