Quality & Regulation Manager

About Igentify

Igentify has created an end-to-end digital genetic platform that makes genomic information more accessible and actionable for clinicians, laboratories, and patients. Recognizing the rising demand for genomic medicine and how its potential to improve health is trapped within complexed, fragmented systems, Igentify’s digital genetic assistant unites and streamlines Genetic analysis and counselling workflows. From customized education about genetic testing, collecting consent and analyzing data, to personalized result videos, Igentify’s platform makes the genetic journey faster and easier. For more information, visit www.igentify.com.

About The Role

The Quality and Regulation Manager is responsible for overseeing the Quality Management System (QMS), regulatory compliance, and information security frameworks to ensure adherence to ISO 13485, FDA, CE, and ISO 27001 standards. This role plays a critical part in maintaining compliance, managing regulatory submissions, and driving a quality and security-conscious culture within the organization.

As part of your duties, you will be responsible for:

Quality Assurance & Regulatory Affairs (QA&RA):

• Manage and maintain the ISO 13485-compliant QMS for the company's software medical device, ensuring compliance with CE and FDA regulations.
• Oversee continuous improvement initiatives to enhance QMS processes.
• Lead the preparation, submission, and maintenance of regulatory documentation required for product approvals.
• Ensure that all business operations align with applicable regulatory and quality standards.
• Oversee the risk management file for the DGA platform, ensuring proper assessment and mitigation of risks.
• Promote a quality-driven culture, increasing awareness of regulatory requirements across the organization.
  
  

• Ensure compliance with EU MDR/IVDR by:
• Verifying device conformity before release.
• Maintaining up-to-date technical documentation and declarations of conformity.
• Overseeing post-market surveillance (PMS) activities.
• Ensuring timely and accurate reporting in accordance with vigilance procedures.
• Managing compliance for performance studies involving risk to participants.
  
  

• Manage and maintain the ISO 27001-compliant Information Security Management System (ISMS) and ensure compliance with ISO 27799 (health information security management).
• Implement and oversee information security requirements across the company.
• Serve as the primary point of contact for external audits, security assessments, and regulatory inquiries related to information security.