Quality and Regulatory Lead

Quality & Regulatory     ·     Dublin     ·     Full time

Omniscient seeks an experienced Quality and Regulatory Lead to work ideally from Ireland but open to any other European country.

About Omniscient

Omniscient Neurotechnology is the “Human Connectome Company”.

Headquartered in Australia, Omniscient is a pioneer in Human Connectomics, a field of neuroscience that investigates the structural and functional connections of the human brain. Such study is providing researchers and clinicians the tools to better understand and treat complex neurological and mental disorders in a hyper-personalized way.

Our technology uses routine MRI scans to produce personalized brain maps via patented cloud and machine-learning based processing techniques. Traits and abnormalities derived from an individual’s brain pathways can allow neurosurgeons, neurologists, psychologists, and psychiatrists the ability to make more accurate diagnosis and create personalized treatment plans for all brain-related disorders.

Our products deliver these maps with enterprise-grade efficiency and usability, enabling broader access to vital subject-specific neurological insights. These insights are rapidly changing the research, diagnosis, and treatment of diseases such as depression, anxiety, dementia, chronic pain, cancer, schizophrenia, bipolar disorder, ADD, ADHD, PTSD & TBI.

Since founding, we have grown exponentially and achieved several world-firsts, such as the development of the world’s first Connectomic neurosurgical planning platform to be cleared by regulatory bodies. Today, we are building the world’s most advanced repository of brain imaging data to facilitate researchers globally with the goal of using machine learning to explore the brain’s 100 billion connections.

With continued development, we intend to improve the lives of billions with both medical and non-medical products and services that drastically change how the human brain is understood, treated, and even enhanced.

To achieve our goals, we have recruited a high-caliber team of professionals in Australia, USA, China, and Canada and are continuing to grow our team globally.

Senior Team

Dr. Michael Sughrue | Co-Founder, Director & Chief Medical Officer

Mike built one of the biggest neurosurgery practices in the US.  With over 230 articles published in scientific journals and as a world authority in the field of Connectomics, Mike brings an unrivalled understanding of the brain to the business of practical clinical outcomes

Dr. Stephane Doyen | Co-Founder, Director, Chief Data Scientist & Chief Technology Officer

As the Head Data Scientist with top-tier consultants, Oliver Wyman, combined with a Ph.D. in neuroscience from Cambridge, Stephane is the ideal technical leader to develop our brain/machine-learning software.

Stephen Scheeler | CEO & Managing Director

Stephen headed up Facebook’s #5 market (ANZ) and was a pivotal figure in scaling Facebook from start-up to US$500+ billion giant. Stephen brings the commercial software business leadership to execute our vision

Key Requirements

• Must have a Bachelor of Engineering, Science, or equivalent
• Must have a minimum of 5 years of experience gained in quality assurance/regulatory affairs
• Must have understanding of and experience with ISO 13485, IEC 62304, and ISO 14971
• Must have experience with regulatory submissions in EU
• Must have experience with clinical evaluation 
• Ability to establish and maintain strong relationships within the organization
• Ability to work independently with little or no supervision

Responsibilities

• Develop and maintain global regulatory portfolio for organization.
• Lead post-market surveillance activities, including planning and reporting (PSUR and PMCF).
• Coordinate clinical validation activities and contribute to strategy, including coordination of literature reviews.
• Assist in Technical Documentation submissions and related QMS compliance efforts.
• Lead and support audits, CAPA investigations, and Quality System Improvements.
• Coach and advocate a culture of quality.

Role

This is a full-time role and will be remunerated at the market rate of the successful candidate based on their experience.

Please click here to apply.