Quality & Regulatory Affairs (QRA) Manager (Remote Europe)
il y a 1 semaine
Start date: As soon as possible
Company Overview:
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.
Job Description:
We're on the lookout for a meticulous and driven Senior QRA Manager 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 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.
Key Responsibilities:
- Develops and implements robust regulatory strategies to support successful deployment of all Ikerian’s SaMD/MDSW products, with emphasis on US and EU markets.
- Ensuring compliance of Ikerian’s products included but not limited to Standard Operating Procedures, and other applicable Standards and Protocols to meet the regulatory requirements of the FDA, EU, EMEA, Customer Specifications, and other regulatory bodies as required.
- Reviews operating procedures from a regulatory perspective to ensure procedures as designed, are in compliance with all regulatory standards and requirements (including FDA/EU/...) to ensure proper function, safety and quality.
- Manage communications with regulatory authorities for the successful development of RetinAI’s regulatory strategy.
- Responsible for vigilance & notifications of incidents to the competent authorities.
- Manage other members of the QRA department and other relevant stakeholders.
- 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).
- Act as main company representative in audits conducted by Notified Body or partners.
- Act as PRRC (Person Responsible for Regulatory Compliance).
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, with a focus on building regulatory strategies for US and EU markets.
- 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.
We invite qualified candidates eager to make a difference in healthcare technology to apply.
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