Software as a Medical Device (SaMD) Regulatory and Product Development Manager


The Company

  • 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 Role


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.

You


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.

To apply or for further information, please submit your CV to recruitment@consultantsinscience.com