Product Development Manager

At ABCDx we are creating the future of point-of-care brain injury diagnostics by turning smartphones into medical devices. By pioneering the ability to decode chemical messages of the brain (brain biomarkers), we developed a clinically validated method to detect brain injury using just a single blood drop.

As we are building our team in Barcelona, we are looking for a X to join us on our adventure. Your mission will be to coordinate the registration and development of our digital platform for diagnostic purposes according to the European and US IVD medical device regulations.

**Join the digital health revolution now and build something bigger than your career**

**You will love this job if**
- You have strong strategic and operational expertise in digital health development from conceptualization to commercialization.
- You are a results-oriented project manager, able to lead and motivate the team and strongly negotiate with all stakeholders
- You are a proactive doer, able to anticipate and resolve conflicts/issues
- You have strong communication and reporting skills

**What you need to reach your full potential**
- 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, ideally a Software as a Medical Device in the digital health 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 follow the EU MDR (ISO 13485:2016), Design History File and documentation that follow IEC 62304 requirements
- Preferably regulation knowledge in diagnostics, specifically ISO-15189, ISO-13485 and 21CFR820.
- Demonstrated experience in the development of technical files, doing risk analyses, preparing analytical and technical validation protocols, preparing regulatory submissions for 510(k) and PMA and certification by Notified Bodies.
- Demonstrated experience of successful regulatory registration of one or more products both in EU and USA.

**You will bring out your full potential by**
- Coordinating the entire software development lifecycle including regulatory affairs, high-level design, and implementation activities
- Being the Project Manager and focal point for all collaboration partners for the development of the digital health products
- Ensuring the development is performed according to the European and US IVD medical device regulations and an ISO-13485 quality management system (QMS).
- Implementing a product development plan, including product risk management, QMS documentation, technical file, and integration of the SaMDS and associated Apps with the (IVD) technology platform
- Conducting meetings with regulatory authorities (FDA and Notified bodies)
- Preparing the documents for the analytical and technical validation (protocols and reports) and final registration of the product.

**What you will find working with ABCDx**
- **Impact**

We are creating the future of point-of-care brain injury diagnostics by turning smartphones into medical devices. Joining ABCDx means a career choice with a meaningful impact on revolutionizing healthcare to save lives.
- **Collaboration**

You will be part of a team that is carefully designed to complement each other in personality, strengths, and weaknesses, where one plus one equals far more than two. At ABCDx we do everything to bring out your full potential at work and within your team.
- **Innovation**

Innovation is at the heart of what we do. However, innovation does not happen just because you say. At ABCDx we try to foster a work environment where innovation is more likely to happen: We encourage creativity and experimentation and we create an environment where people feel safe to speak up and take risks with new ideas, providing tools to learn from failures.
- **Flexible work and accountability**

You will be your own boss. Our culture is one of taking ownership, following through and up on it. We evaluate results not the time spent on your chair.
- **Enthusiasm**

We are a team of people who are genuinely obsessed with their area/work always wanting to learn more and get better at what we do. We work hard, but we enjoy what we do.

**Requirements**:

- 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, ideally a Software as a Medical Device in the digital health 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 follow the EU MDR (ISO 13485:2016), Design History File and documentation that follow IEC 62304 requirements
- Preferably regulation knowledge in diagnostics, specifically