Quality & Regulatory Affairs (QRA) Manager (Remote Europe)

April 25

Retinai

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Improving R&D of first-in-human drug candidates in pharma. Supercharging clinical trials. Elevating the quality of care.

medical image analysis • artificial intelligence • machine learning • med-tech • ophthalmology

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Description

• We're on the lookout for a meticulous and driven Senior QRA Manager to bolster our quality and regulatory operations • The successful candidate will lead the implementation and maintenance of our QMS and the development of our technical documentation in accordance with the internal procedures and medical device regulations and standards

Requirements

• A university degree in Biomedical Engineering, Computer Science, or a related field • A minimum of 5 years of experience in medical device quality and regulatory affairs • Excellent understanding of ISO 13485, EU MDR, IEC 62304 standards, and FDA 21 CFR Part 820 • In-depth understanding in data protection and security regulations, including GDPR and HIPAA • Previous experience with EU and FDA Regulatory Submissions • Previous experience as PRRC (Person Responsible for Regulatory Compliance) and DPO (Data Protection Officer) is valued • Strong project management and interpersonal skills, capable of handling external and internal stakeholders • Self-motivated, able to work autonomously with a high degree of planning and organizational skills • Adept in Microsoft Office and Google Workspace • Resident of a European country and fluent in English

Benefits

• A chance to be part of an exceptional team driving innovation in healthcare • A competitive salary in a supportive work environment that fosters work-life balance • Opportunities for professional growth and development in an international setting • A culture of collaboration and inclusion, which is fundamental to our ethos • Occasional travel to our HQ in Switzerland for audits or team events, immersing you in our core operations and company culture • Provision of hardware and software equipment to facilitate efficient and effective remote work • An opportunity to share in our success through participation in the company's Employee Stock Option Plan