Quality & Regulatory Affairs (QRA) Specialist
Ikerian AG (formely RetinAI Medical) is a fast-growing medical device software company headquartered in Bern, Switzerland. Our mission is to enable the right decisions sooner in healthcare, through transformative AI & data management solutions for disease screening, monitoring. Join our diverse team of entrepreneurs, developers, researchers, and commercial experts who are collectively shaping the future of healthcare.
We're on the lookout for a meticulous and driven QRA Specialist to bolster our quality and regulatory operations. This role is designed for those who excel in a remote setting, are well-versed in the nuances of medical device regulations, and wish to play a crucial role within a vibrant, high-achieving team. The successful candidate will support 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.
Start Date: January 15, 2023
- Facilitate design reviews for product iterations and uphold the integrity of associated technical documentation.
- Enhance our continuous integration practices encompassing development, testing, and release phases.
- Monitor and analyse medical device regulations to ensure submission requirements (CE Marking and 510(k)) and design output requirements.
- Liaise with the research and development teams to effectively address inquiries from Regulatory Authorities and Notified Body.
- Manage data protection and security, particularly in the handling of patient data and real-world evidence, to ensure compliance with relevant regulations (GDPR, HIPAA).
- Ensure clear communication and management of documentation, standards, and procedures within the company.
- Develop and implement new quality processes to accommodate the evolving needs of the company.
- Support audits conducted by Notified Body or partners.
- A university degree in Biomedical Engineering, Computer Science, or a related field.
- A minimum of 2 years of experience in medical device quality and regulatory affairs.
- In-depth understanding of ISO 13485, EU MDR, and IEC 62304 standard. FDA 21 CFR Part 820 / US knowledge is a significant advantage.
- Proficiency in data protection and security regulations, including GDPR and HIPAA.
- Experience in coordinating clinical evaluations and investigations, along with knowledge of respective standards (e.g., ISO 14155), is considered a plus.
- Prior experience with the development and implementation of QMS procedures for the qualification of distributors is highly valued.
- Adept in Microsoft Office and Google Workspace.
- 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.
- Resident of a European country and fluent in English.
- 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.
We invite qualified candidates eager to make a difference in healthcare technology to apply.