QARA Manager

Qualifications

MSc, PhD in Computer Science, Mathematics, Engineering

Required skills

• Good knowledge of Medical device regulation MDR EU 2017/745
• Extensive knowledge of FDA regulations (e.g., 21 CFR Part 820, 21 CFR Part 11/QMSR), ISO 13485, and other relevant global regulations.
• Proven track record of successful regulatory submissions and product approvals.
• Strong understanding of clinical trial design, conduct, and management.
• Experience with quality management systems, including auditing and process improvement.
• Excellent communication skills, with the ability to effectively communicate complex regulatory and clinical concepts to diverse stakeholders.
• Strong leadership and project management skills, with the ability to prioritise tasks, meet deadlines, and drive results.
• Attention to detail and a high level of accuracy in regulatory and clinical documentation.
• Health data compliance systems & regulations knowledge and experience preferred (HIPAA / HDH / CNIL etc.)

Desired regulatory skills

• MDR EU 2017/745
• ISO 13485
• ISO 62304
• ISO 62083
• ISO 27001
• HDS and other related standards and guidances

Missions

• Ensure compliance of Therapanacea products and activities with established policies, rules and procedures, laws and regulation.
• Manage regulatory submissions and approvals: Prepare, review, and submit regulatory filings, including IDEs, PMAs, 510(k)s, and other relevant submissions, ensuring compliance with applicable regulations; liaise with regulatory authorities, such as the FDA, notified bodies, and other global regulatory agencies, to facilitate timely product approvals.
• Coordinate and oversee the preparation of technical documentation, clinical study protocols, reports and other required regulatory documents.
• Establish and maintain quality management systems: develop and implement quality management systems compliant with applicable regulations, including ISO 13485 and other relevant standards; conduct regular internal audits to ensure ongoing compliance and identify areas for improvement; collaborate with cross‑functional teams to address any quality and compliance issues, implement corrective actions, and monitor their effectiveness.
• Train and educate staff: provide training and guidance to employees on commercial (ethics & business integrity), clinical and regulatory compliance requirements and best practices; foster a culture of compliance and awareness throughout the organization by promoting knowledge sharing and continuous learning.
• Manage the QARA team to ensure that the skills needed to successfully carry out our missions are maintained and developed.

Information Security Management System (ISMS) responsibilities

• Ensure the respect and realization of the control, review and audit planning.
• Organise and lead the ISMS management review, the Information Security Steering Committee (ISSC) and the Information System Security Operational Committee (ISSOC).
• Monitor performance indicators and the progress of the ISMS security Dashboard.
• Supervise the document review and validation process by the general management.