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Post Market Surveillance Specialist

Cook Medical

Cook Medical

Bloomington, IN, USA
Posted on Friday, May 31, 2024

Post Market Surveillance Specialist

Requisition ID 2024-14659
Posting Date 2 days ago(5/30/2024 1:41 PM)
Job Location(s)
Bloomington IN United States
Position Type
Full Time
Company
Cook Inc - Bloomington
Category
Regulatory Affairs

Overview

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