Quality & Regulatory Affairs Specialist – FT

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October 1

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Retinai

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Artificial Intelligence • Healthcare Insurance • Pharmaceuticals

RetinAI is a transformative AI and data management platform designed to empower healthcare professionals and pharmaceutical companies in managing data, gaining insights through AI analysis, and enhancing clinical and research workflows. RetinAI's Discovery platform supports real-world evidence, precision medicine, and collaboration across life sciences, pharma, clinics, and academic research institutions. Their solutions focus on ophthalmology, neurodegenerative, vascular, and rare diseases, providing tools for AI-based data analysis, clinical trials, and patient management. With CE-marked models and secure, cloud-based data sharing, RetinAI facilitates global collaboration and accelerates research and treatment outcomes in healthcare.

11 - 50 employees

🤖 Artificial Intelligence

⚕️ Healthcare Insurance

💊 Pharmaceuticals

📋 Description

• Ensure product compliance with FDA, EU MDR, ISO 13485, IEC 62304, and other applicable standards. • Review internal procedures for compliance with global regulations. • Support preparation of technical documentation for CE Marking, UKCA, and FDA submissions. • Prepare and submit FDA 510(k), DeNovo, Breakthrough and Pre-Submission documentation, managing all aspects of CDRH and other related regulatory filings. • Oversee regulatory compliance activities including HIPAA, and future certifications such as MDSAP. • Ensure compliance with FDA QSR - 21 CFR Part 820, ISO 13485 QMS, ISO 14971 risk management, and MDR requirements. • Manage internal and external audits, maintaining readiness and documentation compliance. • Coordinate cross-functional teams, facilitating effective communication and efficient project execution. • Utilize project management methodologies to ensure timely completion of regulatory related initiatives. • Maintain detailed documentation and oversee continuous improvement processes to enhance operational efficiency and compliance.

🎯 Requirements

• University degree in Regulatory Affairs or related field. • 3+ years of experience in medical device quality and regulatory affairs. • Deep knowledge of ISO 13485, EU MDR, IEC 62304, ISO 14971, and FDA 21 CFR Part 820. • Proven experience with EU MDR and FDA submissions. • Experience with audits (Notified Bodies & FDA). • Strong project management and cross-functional collaboration skills. • Excellent communication in English (spoken & written). • Ability to travel occasionally. • If based in Switzerland, Tuesday presence in the office in Bern is obligatory. • Certification in Regulatory Affairs (RAC) is a plus. • Prior experience managing MDSAP certification processes is a plus.

🏖️ Benefits

• Opportunity to be part of a high-impact team shaping the future of healthcare. • Competitive salary and benefits. • Remote-first setup with flexibility and work-life balance. • Career growth and development in an international company. • Inclusive and collaborative culture. • Travel opportunities to HQ in Switzerland for audits, workshops, and team events. • Provision of hardware/software for efficient remote work.