Director of Regulatory & Clinical Affairs
Want to have a direct impact on a patient's health and life and cut down on healthcare costs? Do you have a can-do mindset and not afraid of being a trailblazer?
Then join our growing team at Ignas, where we are pioneering healthcare solutions to combat one of the most critical challenges faced by hospitals today using AI and deep-tech technology.
As a Director of Regulatory & Clinical Affairs at Ignas, you'll play a crucial role in ensuring the highest standards of quality and compliance in the development of our medical devices working closely with top hospitals worldwide. Your responsibilities will encompass managing our Quality Management System in alignment with ISO 13485, guiding the clinical validation studies, and navigating through MDR2020 and FDA regulations andour strategy regarding those. By working closely with both internal teams and external healthcare professionals, you will ensure our solutions not only meet regulatory requirements but also address the real-world needs of healthcare settings.
Projects and Responsibilities:
Quality Management Systems: Lead the implementation and maintenance of Quality Management Systems (eQMS (Quolio)) specific to medical device development, ensuring compliance with ISO 13485 and all relevant standards.
Regulatory Compliance: Oversee the medical device development process to ensure adherence to MDR2020 and FDA regulatory requirements, applying your knowledge to navigate the complexities of medical device regulations effectively that will result in a product to market.
Clinical Validation Studies: Design and execute clinical validation studies, working closely with hospitals, universities, and healthcare workers to ensure our medical devices meet the needs of real-world clinical environments.
Regulatory Affairs: Contribute to Quality Assurance and Regulatory Affairs by maintaining regulatory documentation, managing regulatory processes, and providing guidance to ensure continuous compliance across all product stages, from inception through Post-Market Surveillance.
Stakeholder: Act as a key member with regulatory authorities, notified bodies, and other external stakeholders such as hospitals, maintaining positive relationships to facilitate smooth regulatory approvals and compliance.
Education and Competency:
Educational Background: Bachelor’s degree in a related field, with any additional qualifications and experience in medical device regulatory affairs considered an advantage.
Quality Assurance and Regulatory Affairs Experience: Demonstrable experience in a QA or Regulatory Affairs role within the medical device industry such as Class 1, with hands-on experience working with technical files and a solid understanding of EU MDR requirements.
Regulatory Knowledge: Up-to-date knowledge of medical device regulatory requirements in the EU and US, with experience working within a Quality Management System.
Clinical and Technical Proficiency: Experience in preparing and maintaining regulatory submissions, and technical files, and conducting clinical evaluation and validation research and reports. Knowledge of designing for compliance with global medical device standards, including packaging, labeling, and marketing materials.
Communication and Leadership: Strong communication skills to support cross-functional teams, manage external stakeholder relationships, and lead assigned regulatory projects.
As part of our team, you'll enjoy a range of perks designed to support your professional growth and personal well-being. After all, we aim to save patients' lives!
We offer snacks to help you stay energized and you´ll also be required to use the best available AI tools and technologies that will empower you to bring your innovative ideas to life. We understand the importance of work-life balance and offer flexible working hours.
We offer competitive salaries and we have an impressive vesting plan for key employees.
Enska