QA & Regulatory Manager

iKnowHealth S.A. is seeking a QA & Regulatory Manager to join our team. As a leading provider of software solutions for the healthcare and radiology industries, our goal is to improve productivity, enhance access to information, and lower the overall cost of managing large volumes of data efficiently and effectively.

We specialize in developing and distributing the Evorad® certified clinical software, a complete RIS / PACS / WORKSTATION suite that covers all the needs of a radiology department. Our software offers customizable user roles, multi-task scheduling, complete audit trails, and customizable medical reports.

We will be glad to have you on our team as a QA & Regulatory manager.

Key Responsibilities:

• Implement quality strategies to ensure regulatory compliance, while collaborating cross-functionally to enhance process efficiency

• Support the implementation of the Integrated Management System, driving effective planning, operational control, and the maintenance of all necessary certifications (ISO 9001, 13485, 14001, 45001, 37001, etc.)

• Contribute to regulatory activities for market access, ensuring adherence to relevant regulations and standards in the medical devices/healthcare sector (including MDR, CE marking, ISO 13485, and other international regulatory requirements). Identify and implement the necessary steps for product registration and compliance in different countries/markets, supporting field (safety) corrective actions, medical vigilance, and post-market surveillance processes

• Implement EHS activities across the organization, promoting a culture of safety, compliance, and continuous improvement

Requirements:
• BSc/MSc in a related subject, within the fields of Engineering, Chemistry, Biology, or Pharmacy

• 5+ years of professional experience in a similar role within the medical devices industry

• Strong understanding of applicable regulatory requirements and standards, including MDR, CE marking, ISO 13485, and other country-specific regulations and registrations

• Ability to evaluate and apply regulatory requirements for new markets globally

• Strong analytical and problem-solving skills

• Comfortable working in fast-paced, dynamic environments

• Strong communication and stakeholder management skills, with a team player mindset

• Fluent in Greek and English, written and spoken

Benefits:
• A stable and enjoyable working environment
• An attractive salary package
• Career development and growth opportunities
• An amazing private & open-office workspace in Athens #LI-Hybrid
• Continuous training via personalized seminars