Medical Device Regulatory/Quality Engineer - Eyenuk, Inc.

13485, 14971, 62304, 62366, 82304 - are these more than just numbers to you? Are you passionate about bringing cutting edge technology after a ritual of “regulatory fire” to benefit patients and clinicians alike? Read more and apply for a position in an established and dynamic start-up.

About Eyenuk:

Eyenuk, Inc. headquartered in Woodland Hills, Los Angeles develops AI-based software medical devices for screening, monitoring, and diagnosis of eye disorders such as diabetic retinopathy and glaucoma and systemic disorders such as cardiovascular disease and dementia. The EyeArt AI system is the first FDA cleared AI technology for autonomous detection of both more than mild and vision-threatening diabetic retinopathy. EyeArt also has CE marking in the European Union and a Health Canada license. Eyenuk's team has also successfully completed audits under MDSAP, EU MDR, and for ISO 13485 compliance.

Required Education/Experience:

Masters in Regulatory Science or equivalent, or at least 4 years regulatory and quality assurance experience

Essential Functions:

• Work with a team to interface with domestic or international regulatory agencies regarding applications, audits, reports, or correspondences in a timely, accurate, and comprehensive manner.
• Interact with teams to provide regulatory guidance regarding the design, development, evaluation, labelling, and marketing of products.
• Maintain current knowledge of relevant regulations and monitor emerging trends regarding industry regulations to determine potential impacts.
• Ensure standard operating procedures and work instructions are compliant with current regulations and standards; ensure staff are adequately trained and compliant with current QMS procedures.
• Communicate information in a clear, precise, and timely manner to all relevant teams.
• Participate in the protocol development and implementation of clinical studies.

Competencies:

• Excellent verbal and written communication skills
• Excellent organizational and time management skills
• Excellent decision-making and creative problem-solving skills
• Ability to develop, organize, and manage multiple tasks
• Ability to work independently
• Proficient in use of computer and software systems
• Ability to understand, interpret, and explain complex regulatory requirements and details
• Demonstrate knowledge and clear understanding of overall medical device development processes
• Software development experience or an engineering background is a bonus