Our client is headquartered in Geneva, Switzerland and discovers and develops mobile diagnostic tools to transform care for patients with brain injuries.
They are developing a digital platform to support diagnosis and clinical decision-making based on cutting-edge AI technologies
The SaMD regulatory and product development manager will be required to:
Coordinate the registration and development of the company's digital platform for diagnostic purposes according to the European and US IVD medical device regulations.
Coordinate the entire software development lifecycle including regulatory affairs and high-level design and implementation activities.
Intensively work with the CSO and CMO and liaise with the company’s collaboration partners for the development of digital health products.
Ensure the development is performed according to the European and US IVD medical device regulations and an ISO-13485 quality management system (QMS).
Responsibilities include but are not limited to: implementation of a product development plan; product risk management; preparing applicable QMS documentation, developing the technical file; integration of the SaMDS and associated Apps with the (IVD) technology platform; meetings with regulatory authorities (FDA and Notified bodies); preparation of the analytical and technical validation documents (protocols and reports); and final registration of the product.
Our client is looking for someone who is an experienced SaMD regulatory and product development manager with the following qualifications and experience::
Preferably hold a master's or PhD in Computer Science, Information Systems or equivalent.
Minimum three (3) years of experience in managing SaaS product development
Strong strategic and operational experience in digital health development from conceptualization to commercialization.
Preferably affinity and experience with the development of Software as a Medical Device in the digital health-based diagnostic / IVD arena.
Thorough working knowledge of all IVD digital health aspects of CE-Marked and FDA-regulated Class I, II, and III medical devices.
Experience in IVD and Medical Device Single Audit Program (MDSAP), in QMS that complies with the requirements of the EU MDR (ISO 13485:2016), Design History File and documentation that follow IEC 62304 requirements.
Preferably experience in diagnostics in regulated environments, specifically ISO-15189, ISO-13485 and 21CFR820
Demonstrated experience in successful regulatory registration of one or more products both in EU and USA.
Ability to efficiently plan and manage the SaMD development as well as the required budgets
Experienced working in a highly dynamic start-up environment
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.
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