Post Market Surveillance Specialist - Remote

Posting Date 1 month ago(8/23/2022 1:44 PM)
Requisition ID
Job Location(s)
Bloomington IN United States
Position Type
Full Time
Cook Inc - Bloomington
Regulatory Affairs


The Post Market Surveillance Specialist is to support the reporting process, assuring compliance with national and international regulations.

Monitor the performance of a medical device after release to the market. Ensure Post Market Surveillance plans and reports are consistent

with applicable regulations, standards, and established procedures.


• Collaborate with functional teams to collect, review, and analyze data for the Post Market Surveillance (PMS) process

• Schedule and facilitate Post Market Surveillance meetings to discuss plans and reports

• Collect, review, and edit Post Market Surveillance data for Clinical Evaluation Reports

• Generate plans and reports to ensure compliance with evolving regulations

• Monitor, track, and communicate project progress to leadership

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

• 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

• 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, which may include oral or written

• Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision

• Ability to remain calm and receptive in fast paced situations


• Bachelor’s degree required 

• 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:

• 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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