Company Overview
Ligence ❤️ is at the forefront of medical technology, revolutionizing echocardiography with AI-powered Software as a Medical Device (SaMD). In a groundbreaking achievement, our research with real-world clinical data demonstrated that AI has outperformed humans in echocardiography for the first time in history. This milestone marks a new era in cardiac care, offering unprecedented accuracy, efficiency, and reliability. We are seeking an experienced Head of Quality and Regulatory Affairs to ensure our innovations meet the highest global quality and compliance standards.
Why Join Ligence?
At Ligence, you’ll be part of a team rewriting the rules of healthcare. This is not just a job—it’s your chance to contribute to technology that changes lives, sets new benchmarks, and redefines patient care. Together, we’re shaping the future of echocardiography
Position Overview
As the Quality Assurance Lead, you will lead the charge in ensuring the quality, safety, and regulatory adherence of our SaMD product. This pivotal role demands expertise in navigating FDA regulations, CE marking under MDR 2017/745, ISO 13485, ISO 27001, ISO 27018, HIPAA, GDPR, UK, Swiss standards, and other emerging markets. The successful candidate will be instrumental in maintaining a robust Quality Management System (QMS) while actively contributing to global regulatory compliance efforts.
Responsibilities
1. Quality Management System (QMS) Leadership:
- Develop, implement, and maintain an inclusive QMS compliant with FDA regulations, ISO 13485, ISO 27001, ISO 27018, HIPAA, GDPR requirements.
- Provide strategic leadership to cross-functional teams on quality-related initiatives.
2. Regulatory Compliance:
- Lead efforts to obtain and maintain regulatory approvals, including FDA clearance(in-process), CE marking under MDR 2017/745 (obtained), and compliance with international standards and regulations.
- Stay current with regulatory changes and ensure continuous compliance in new markets.
3. Risk Management:
- Conduct risk assessments and collaborate with the development team to integrate risk management practices throughout the product life cycle.
4. Quality Assurance:
- Implement and oversee quality assurance processes to ensure product quality and safety.
- Conduct regular internal audits and management reviews to assess and improve the effectiveness of the QMS.
5. Global Standards Adherence:
- Ensure compliance with HIPAA, GDPR, UK, Swiss standards, and other emerging market regulations.
- Stay informed about global regulatory requirements and adapt quality processes accordingly.
Qualifications
-At least 2 years of hands-on experience in quality assurance and regulatory affairs, with a proven track record of working under MDR and FDA regulations .
- Experience with SaMD (software as a medical device) and medical imaging is strongly preferred.
- Basic understanding of software systems and python language is strongly preferred.
- Certification of MDR training is a must.
- Internal auditor certification and experience with ISO 13485 and ISO 27001 are highly desirable.
- In-depth knowledge of FDA regulations, CE marking under MDR 2017/745, ISO 27018, HIPAA, GDPR, UK, Swiss standards, and emerging market requirements.
- Strong understanding of risk management principles and practices.
- Excellent communication, leadership, and interpersonal skills.
What we offer
- Competitive salary: 8000 - 4000 EUR, depending on previous experience and FTE.
- Hybrid Work Setup - flexibility to choose between working from our city-center office or remotely.
- Emphasis on work-life balance with a personalized approach to suit individual preferences.
- Support for New Training - continuous learning opportunities to stay at the forefront of the industry. Financial and logistical support for training programs and certifications to enhance professional skills.
- Possibility to Learn and Improve in AI Regulatory Field - exposure to the highly growing regulatory field of AI with hands-on projects and challenges.
- Opportunities for career advancement and skill development in an intellectually stimulating environment.
