For our client based in Geneva, we are looking for an experienced IVD Product development specialist to manage the development and registration of their digital rapid point of care testing (POCT) tests for in-vitro diagnostic purposes according to the European and US IVD regulations.
The company discovers and develops diagnostic tools transforming care for patients with brain injuries. The company's devices help the healthcare professionals in the triage, diagnosis, and treatment decision process at the point of care for patients presenting with potential brain injury from stroke and trauma to post-injury complications and patient outcomes. The company is pioneering the ability to decode the chemical messages of the brain (brain biomarkers) so that brain injury can be detected in a drop of blood from a finger prick, allowing the diagnosis at the admission of the emergency department before hospitalization or even directly on the field where the injury occurred.
Role and responsibilities:
The IVD product development manager will join the operational team and will lead the IVD product development activities and will ensure IVD registration in Europe (CE) and the US (FDA).
The IVD product development manager will intensively work with the CSO and CMO and liaise with the company’s collaboration partners for the development of the products.
The product development manager will ensure the development is performed according to the European and US IVD regulations and an ISO-13485 quality management system (QMS). The responsibilities include but are not limited to the implementation of a product development plan, product risk management, preparing applicable QMS documentation, developing the technical file, integration of the assays and associated Apps with the (IVD) technology platform, (pre-application) meetings with regulatory authorities (FDA and Notified bodies), preparation of the analytical and technical validation documents (protocols and reports) and final registration of the assays.
Qualifications and skills:
Master's or PhD in biomedical sciences, analytical chemistry, molecular biology, or related field.
Thorough working knowledge of all aspects of FDA and EU IVD regulations
Ability to efficiently plan and manage IVD development as well as the required budgets
Good IT skills in, e.g. MS Office and MS project are essential, for planning, tracking, communicating, and reporting
Demonstrated management, leadership, motivation, influencing, negotiation, and communication skills.
Strong organizational, analytical, and planning abilities, results-oriented, hands-on, flexible, respect for quality and compliance, proactive and able to anticipate and resolve conflicts/issues, reactivity to emergent needs, able to prioritize, time management.
Effective communication and reporting skills
Fluent in English.
Minimum three years of experience managing IVD product development
Experience in the development of POCT based in-vitro diagnostic detection systems
Strong strategic and operational experience in diagnostics development from conceptualization to commercialization.
Demonstrated experience of successful IVD registration of one or more products both in the EU and USA.
Experience focused on brain biomarkers, immunological assays, and personalized medicine.
Demonstrated experience in the development of technical files, undertaking risk analyses, preparing analytical and technical validation protocols, preparing regulatory submissions for 510(k) and PMA and certification by Notified Bodies.
Experience working in a highly dynamic start-up environment as well as larger diagnostic development companies
Experience in diagnostics in regulated environments, specifically ISO-15189, ISO-13485 and 21CFR820. Additional knowledge of CLIA and CAP systems is a preference.
Experience with CLSI standards
Experience in statistics is a preference
To apply or for further information please email firstname.lastname@example.org