🤠 Missions

As a Regulatory Manager for Gleamer, you will be responsible for ensuring that our company’s SAMD (Software as a Medical Device) products meet regulatory standards.

You will work closely with cross-functional teams to ensure that our products comply with relevant regulations and guidelines and that they are safe and effective for use by clinicians in radiology.

You will play a critical role in the development and approval of our SAMD products, and you will have the opportunity to make a significant impact on the healthcare industry.

🥇 Responsibilities

• Develop and implement regulatory strategies for CE marking and FDA clearance.

• Collaborate with R&D, Clinical Affairs, and QA teams to integrate regulatory requirements throughout product development.

• Prepare and submit regulatory documentation, including 510(k) premarket notifications and CE technical files.

• Manage regulatory documentation, product files, technical files, and post-market surveillance activities.

• Participate in regulatory agency meetings, inspections, and audits.

• Monitor regulatory changes and provide proactive guidance to the organization.

• Support the creation and maintenance of regulatory processes and procedures.

• Provide regulatory guidance on labeling, advertising, and promotional materials.

• Stay updated on regulations, guidelines, and standards in the medical device, software as a medical device, AI, and CAD fields.

✅ Hard skills

• Strong knowledge of global medical device regulations, including EU MDR and FDA regulations.

• Experience with CE marking and 510(k) submissions.

• Familiarity with AI technologies, CAD devices, and software development regulations.

• Understanding of risk management, quality management systems, and cybersecurity

• Fluent in English

👂 Soft skills

• Strong analytical skills and attention to detail

• Excellent written and verbal communication skills

• Strong problem-solving skills and ability to think critically

• Ability to work independently and as part of a team

• Strong interpersonal skills and ability to communicate effectively with cross-functional teams

• Ability to prioritize and manage multiple tasks and projects

• Willingness to learn and adapt in a fast-paced startup environment

😄 Profile

• Master’s degree in engineering, biomedical engineering, or a related field

• At least 2 years of regulatory affairs experience (or related roles) in the software as a medical device industry

• Master’s degree in engineering, biomedical engineering, or a related field

• At least 2 years of regulatory affairs experience (or related roles) in the software as a medical device industry