Job Location : Worcester, UK
Our client is a growing company in the medical device sector that designs and manufactures several implantable orthopaedic devices and their associated surgical instruments. As part of their expansion plans, they are looking for a PMS Associate to gather and collate clinical data to meet regulatory requirements, and to drive continued product improvements in close collaboration with orthopaedic professionals. This person will report to our Vice President - QA/RA.The devices they manufacture are of high classification, and hence they require rigorous post-market surveillance and post-market clinical follow-up studies to be managed under a certified quality management system.
Requirements
Key requirements
Ideally, you will have experience or understanding of the medical device or orthopaedic industry. Knowledge of ISO 13485, 21 CFR Part 820, and the Medical Device Regulations is desirable.
You will be expected to create regulatory documentation to support the company’s medical devices, and by working with others within the business, improve their efficacy. You will also be able to provide appropriate input during internal and external audits.
Job Responsibilities:
o Direct feedback from user surgeons
o Customer complaints
o Patient Reported Outcome Measures (PROMs)
o Product information from joint registries
o Vigilance databases
o Published clinical literature
Required Job Skills:
Salary : 30000 - 35000
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