About Us
Are you inspired by the intersection of healthcare innovation and cutting-edge AI technology? We are a fast-growing company delivering AI-powered radiology software. Our mission is to empower healthcare professionals to make faster, more data-driven diagnostic decisions through innovative medical imaging solutions, ultimately improving patient care.
As we expand, we’re looking for a Quality and Regulatory Associate to join our team in Athens. This is a fantastic opportunity to contribute to the compliance and quality management of life-changing medical technology in a collaborative, fast-paced environment.
Why Join Us?
- Impactful Work: Play a crucial role in ensuring the safety and compliance of AI solutions that assist healthcare professionals worldwide.
- Growth Opportunities: Grow your career with a company that values your potential, offering avenues for specialization in regulatory affairs or quality management.
- Innovation: Be part of a team developing breakthrough technology at the forefront of healthcare AI.
- Global Reach: Collaborate with a diverse team, working on products deployed across Europe, the U.S., and beyond.
Your Role
As a Quality and Regulatory Associate, you’ll ensure our products comply with international regulatory standards and maintain high quality and safety standards. You’ll also contribute to the overall operational excellence of the company.
Key Responsibilities:
Regulatory Compliance:
- Ensure ongoing compliance with ISO 13485 standards and maintain certification.
- Assist in preparing regulatory submissions, such as 510(k) pre-market notifications for the FDA and CE marking applications for the EU.
- Monitor changes in regulations and update internal processes as necessary.
Quality Management System (QMS):
- Manage and update the QMS, ensuring it aligns with company operations.
- Conduct internal audits, prepare for external audits, and implement corrective and preventive actions (CAPAs).
- Oversee technical documentation, including risk management and product validation records.
Risk Management:
- Support risk analysis, hazard identification, and mitigation planning for software products.
- Maintain up-to-date risk management documentation.
Team Collaboration & Administration:
- Work with cross-functional teams to align on quality and regulatory goals.
- Provide training on regulatory and quality requirements to internal teams.
- Contribute to operational activities such as audit preparation, documentation, and feedback management.
Who We’re Looking For
We’re looking for individuals with diverse professional and academic backgrounds who are excited to contribute to medical device regulations.
Must-Haves:
- At least 1 year experience in a relevant regulatory/compliance position.
- Bachelor’s degree in a relevant field (e.g. Law, Administration, Biomedical Engineering, Engineering, Physics, Medical Physics, Quality Management, Project Management.)
- Prior experience with ISO 13485 standards or similar frameworks (i.e. ISO 9001, ISO 27001).
- Strong organizational skills with an eye for detail.
- Excellent verbal and written communication in English.
- Interest in regulatory processes.
Nice-to-Haves:
- Experience in medical device compliance or a related field.
- Familiarity with software as a medical device.
What We Offer
- Competitive Compensation: Based on experience, with performance-based bonuses.
- Hybrid Work Setup: Flexibility to work both remotely and at our Athens office.
- Comprehensive Benefits: Private health insurance and a monthly food allowance card.
- Learning Opportunities: Gain hands-on experience in regulatory and quality management, with mentorship from industry experts.
- Tools for Success: A company-provided laptop and resources for professional growth.
If you’re passionate about the medical device industry, have a keen interest in regulations, and thrive in a collaborative environment, we’d love to hear from you!