Staff Regulatory Affairs Engineer
Hinge Health is seeking a Staff Regulatory Affairs Engineer to lead regulatory strategies for their AI/ML Software as a Medical Device (SaMD) portfolio. This role combines technical expertise with regulatory knowledge to ensure compliance and facilitate product development.
The Staff Regulatory Affairs Engineer will be responsible for authoring and managing regulatory submissions, including 510(k), De Novo, and Pre-Submissions, for AI-enabled software products. Collaboration with Product, Clinical, and Engineering teams is essential to interpret FDA guidelines for AI/ML, navigate complex pathways like Predetermined Change Control Plans (PCCP), and maintain the Quality Management System (QMS) to support rapid innovation.
Candidates should possess a Bachelor's degree in Biomedical Engineering, Software Engineering, Regulatory Science, or a related field, with 4-6 years of experience in Regulatory Affairs within the medical device industry, including at least 3 years focused on Software as a Medical Device (SaMD) or Digital Health. A proven track record in authoring and clearing US FDA Class II submissions (510(k) or De Novo) and technical fluency in software architecture, cloud infrastructure, and AI/ML concepts are required.
The compensation for this role ranges from $168,000 to $252,000 annually, complemented by equity and benefits. Hinge Health offers comprehensive medical, dental, and vision coverage, support for gender-affirming care, family and fertility planning tools, and travel reimbursements for healthcare services not available locally. Additional benefits include a 2% company match on 401(k) retirement plans and learning and development stipends.
Hinge Health is dedicated to delivering patient-centered digital healthcare solutions, focusing on musculoskeletal health. The company fosters a culture of continuous growth and development, emphasizing feedback, open communication, and mutual trust. Employees have the opportunity to lead in the health space and make a significant impact on patients' lives.