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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:
- Establishment of post-market surveillance and post-market clinical follow-up plans
- Completion of post-market surveillance reports including Periodic Safety Update Reports (PSURs) and Summaries of Safety and Clinical Performance (SSCPs)
- Proactive gathering of post market data directly from healthcare professionals
- Management of clinical data collection from a variety of sources including:
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
- Assist in activities of Clinical Research Organisations (CROs) during clinical investigations as required
- Input into Clinical Evaluation Reports (CERs)
- Input into internal product reviews
- Input into vigilance reporting to regulatory authorities
- Input into customer complaint investigations
- Input into technical file documentation relating to clinical performance and associated risks
Required Job Skills:
- Attention to detail is essential
- Report writing ability
- Data analysis
- Strong problem-solving skills
- Personable manner to develop relationships with external partners including orthopaedic surgeons
- Ability to work with staff at differing levels of the organisation
- Competence to assess and upgrade procedures and systems as required
- Strong communication skills
- A team player
- Versatile and a self-starter able to work without supervision.
