Clinical Device Expert - Les Bons Villers Mellet, België - Keyrus Life Science Belgium
Beschrijving
We are looking for
Clinical Devices Support who is
methodical, detail-oriented, with excellent interrelation skills to join us in our Pipeline Devices team, based in Braine-l'Alleud, Walloon Brabant, Belgium.
About the role
This position will focus on ensuring patient safety and compliance with regulations for all clinical studies collecting primary data and requiring IRB/EC approval in all geographical area.
Who you'll work with
What you'll do
-
Implement the overall strategy for the various medical devices to be used in the clinical trials.
- Be part of the Clinical Devices team to
ensure appropriate setup of selection and assessment of medical devices to be used in the clinical trials. - Work with clinical teams
to collect their needs (current and to come) and
assess their fit to purpose.
Perform the technical assessment for devices used in clinical trials.
Interested? For this role we're looking for the following education, experience and skills:
- A
master's degree with a relevant academic background
5-8+ years of experience in a medical devices/pharmaceutical environment
- Understanding of the issues and challenges of selecting appropriate and fit for purpose devices from
FIH to Phase 4 clinical trials studies: - Thorough
knowledge and understanding of Medical Devices Regulations (EU MDR, 21CFR part 820)
What we offer
At Keyrus, thanks to the expertise of our people and external partners, each employee is welcomed with a varied integration program.
We invest considerable time and resources in training our staff (technical and non-technical courses) to continuously support you in your personal and professional growth.
On top of this, you will receive a complete salary package including attractive extra-legal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization ) based on your background and experience.
Who we are
Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence.
At Keyrus Life Science we're proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients' projects, priorities and reputation.
From early
- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.
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