QARA Manager

MSc, Phd in Computer Science, Mathematics, Engineering

Required Skills

• Good knowledge on 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 prioritize 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
• 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) Manager Responsibilities

• Ensure the respect and realization of the control, review and audit planning
• Organize 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;
• Supervising the document review and validation process by the general management.