The Epione platform, with its Helpilepsy & MigraineManager verticals, is used and loved by hundreds of people with neurological disorders and their physicians, in both clinical practice and clinical research settings. As a medical device class I manufacturer (software medical device), we are now looking to strengthen our quality & clinical data capabilities.
As our new QA/RA and Clinical Data Manager, you will lead our quality commitment with the full support of the leadership team, as well as define, manage and execute our clinical data strategy. The end goal is to be at the forefront of software medical devices in terms of quality, clinical proof points and reimbursement by insurers. For this key strategic and innovating role, you will work hand-in-hand with the leadership team.
Establish the QA/ and RA strategy, approach, and execution of our startupwithin a range of development activities
Own our the Quality Management System (QMS) MS process , following ISO 134285
Ensure good transition from external to internal QA/RA
Elaborate the Epione study roadmap for both Helpilepsy ands MigraineManager in collaboration with medical advisors
Design and execute Epione specific studies (protocol, CRF, clinical database validation, compliance and approvals)
Support clinical trials using Epione products on data management (link to sponsor and CRO)
You are a motivated & self-driven person, looking for a new challenge
You are eager to learn and innovate in a new field: Software medical devices, reimbursement strategy, clinical studies with software
You have 3+ years of relevant experience in medical devicedevices QA/RA functions and/or in clinical trial management
You have good knowledge of medical devices quality assurance (ISO 13485, 21 CFR) and relevant standards
You have experience in data management in clinical trials and/or experience with market access and reimbursement strategies
You are detail-oriented and structured, but at the same time flexible and results-oriented
You have the experience and/or the will to work in a startup environment
You speak English fluently, ideally in combination with good/fluent Dutch and French
The opportunity to reinvent healthcare with real impact on people’s lives and healthcare providers
Challenging and innovative work environment with a driven team
The opportunity to be at the forefront, worldwide, on quality, clinical and reimbursement aspects of a software medical device
Flexibility and responsibility instead of a 9-to-5 mentality
Interested in having a high-impact contribution, in a growing company, for the healthcare of tomorrow ?
Send your application to Ludovic.firstname.lastname@example.org and join the team !
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