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

Retinai

Retinai

Legal, Quality Assurance
Brussels, Belgium
Posted on Wednesday, April 24, 2024

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:

  • Builds, produces and maintains world class regulatory systems, structures, processes, capabilities and skills to support the successful deployment of all Ikerian’s SaMD products globally at all stages in the product life cycle.
  • 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).