Medicalholodeck.com stands at the intersection of medical education and cutting-edge virtual reality technology. Our VR platform is designed to transform how medical professionals and students interact with medical imaging and anatomy, making learning more immersive and intuitive. As we push the boundaries of medical and VR technology, we are mindful of the importance of compliance with regulatory standards. In light of this, we seek a Medical Regulatory Assistant to support our efforts in navigating the regulatory landscapes, particularly with the FDA (U.S. Food and Drug Administration) and CE marking (Conformité Européenne) for our software products.

The Medical Regulatory Assistant will be instrumental in ensuring our software complies with all relevant regulatory requirements for medical devices in the U.S. and Europe. This role involves collaborating with our product development and legal teams to prepare submissions, maintain documentation, and stay abreast of regulatory changes that may affect our products.

• Educational Background: Bachelor's degree in Regulatory Affairs, Biomedical Engineering, Life Sciences, or a related field.
• Experience: Previous experience in regulatory affairs, particularly with FDA 510(k) submissions and CE marking processes for medical devices or software. Familiarity with international medical device regulations is a must.
• Knowledge of Regulatory Frameworks: Understanding of regulatory requirements for medical software in the U.S. and EU, including FDA regulations, CE marking directives (e.g., MDR, IVDR), and ISO standards (e.g., ISO 13485, ISO 14971).
• Analytical Skills: Strong analytical and problem-solving skills, with the ability to interpret regulatory guidelines and apply them to product development.
• Communication Skills: Excellent written and verbal communication abilities in English, with the skill to communicate complex regulatory concepts clearly and effectively.
• Organizational Skills: Detail-oriented with strong organizational capabilities, able to manage multiple projects and deadlines.

• Assist in preparing regulatory submissions for the FDA and CE marking, ensuring all necessary documentation is accurate, complete, and compliant.
• Monitor and interpret changes in regulatory legislation and guidelines, advising on their implications for our products.
• Collaborate with product development teams to ensure regulatory considerations are integrated into product design and development.
• Maintain comprehensive records of regulatory correspondence and documentation.
• Support internal and external audits related to regulatory compliance.
• Act as a liaison between Medicalholodeck and regulatory bodies, facilitating effective communication and submission processes.