TheraPanacea is seeking a Manager of Regulatory Affairs, Quality & Compliance to lead global regulatory strategy, quality systems, and compliance across our medical technology portfolio. This role is responsible for securing and maintaining regulatory approvals (FDA, CE and other markets), building and maintaining a ISO–compliant Quality Management System, and ensuring strong governance across regulatory, ethics, and information security. As a key member of the leadership team, you will advise senior management on regulatory and compliance risks, interface with health authorities, and lead high-performing Regulatory, Quality, and Compliance teams to support safe, compliant, and scalable product commercialization.

Minimum level required: MSc in Computer Science, Mathematics, Engineering, 7+ years of experience in related positions

Required skills:

● Extensive knowledge of FDA regulations (e.g., 21 CFR Part 820, 21 CFR Part 11), 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: ISO 13485 , IS0 27001, HDS , MDR EU 2017/745 and other related standards and guidelines

• Human Resources

• Compliance