Accelerating access to certified medical AI solutions
Scarlet is a health tech compliance company based in Fitzrovia, London, focused on certifying medical AI and software to enhance patient access to innovative healthcare solutions. With $27.6 million in funding, Scarlet is addressing the inefficiencies in the certification process, which has traditio...
Scarlet offers competitive equity options, flexible PTO policies, and a remote-friendly work environment to support work-life balance....
Scarlet fosters a culture of agility and innovation, prioritizing software solutions in healthcare compliance. Their close collaboration with regulato...
Scarlet • Remote
Scarlet is seeking a Lead Auditor to conduct remote audits of medical device manufacturers' Quality Management Systems. You'll ensure compliance with ISO 13485, EU MDR, and UK MDR standards. This contractor role offers flexible scheduling and the opportunity to work in the innovative field of medical AI.
You are an experienced auditor with a strong background in regulatory compliance, particularly in the medical device sector. You have the necessary qualifications to be authorized as a Lead Auditor in a Certification or Notified Body under ISO 13485, EU MDR, and UK MDR. Your expertise allows you to independently deliver high-quality audits that meet stringent regulatory standards. You are detail-oriented and capable of providing clear, structured audit documentation and evidence-based conclusions. You thrive in a flexible work environment and are comfortable conducting remote audits. You understand the importance of ensuring that innovative medical device companies meet the highest regulatory standards and are passionate about contributing to the advancement of healthcare.
In this role, you will conduct remote audits of medical device manufacturers' Quality Management Systems under ISO 13485, EU MDR, and UK MDR. You will be responsible for delivering audits in line with Scarlet’s standards, approach, and culture. Your role will involve providing clear and structured audit documentation, ensuring that all findings are evidence-based and well-documented. You will engage with various stakeholders during the audit process, offering insights and recommendations for compliance improvements. You will work flexibly, supporting audit delivery as part of Scarlet’s notified body activities, adapting to audit demand and your availability. Your contributions will help ensure that cutting-edge healthtech meets regulatory requirements, ultimately facilitating the safe and effective delivery of medical AI technologies to patients.
Scarlet offers a unique opportunity to be part of a team that is at the forefront of the medical AI revolution. You will have the chance to work with some of the most innovative companies in the healthcare sector, contributing to the transition to universally accessible healthcare. The role is fully remote, allowing for flexible scheduling that accommodates your availability. You will be part of a mission-driven organization that values quality and compliance, and you will play a crucial role in ensuring that medical devices meet the highest standards. We encourage you to apply even if your experience doesn't match every requirement, as we value diverse backgrounds and perspectives.
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