About our organization
We are on a mission to optimize the delivery of world-class care, aiming for every clinician to practice with AI systems that free them from administrative burdens and increase quality and accessibility of care to patients globally.
The Role
* Drive regulatory strategy: Develop and implement quality and regulatory strategies for product development and commercialization in the UK and EU.
* Lead conformity planning: Manage medical device readiness, taking a lead role in detailed MDR and UKCA conformity planning and execution.
* Provide proactive regulatory guidance to cross-functional teams (Product, Clinical, Marketing) throughout the product lifecycle.
* Manage technical documentation: Develop, compile, and maintain UK/EU technical files, coordinating with internal teams and stakeholders.
* Manage post-market activities: Establish and manage Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) activities.
* Ensure quality: Drive continuous improvement and maintenance of our Quality Management System (QMS) to ensure compliance.
Requirements
* 3-5 years of hands-on experience in regulatory affairs within the UK and EU markets, including medical devices and ideally covering data governance, privacy, and emerging technology regulations like the EU AI Act.
* A strong ambition and readiness to lead projects and make a significant impact in a high-growth environment.
* A strong working knowledge of EU MDR 2017/745 and UKCA marking requirements, with familiarity with the emerging EU AI Act being a significant plus.
* Demonstrated ability to drive tasks to completion and excellent communication and collaboration skills.