Responsibilities
- Take ownership of preparing, writing, and submitting regulatory documents such as 510(k)s, De Novo requests, and Q-Submissions for artificial intelligence and machine learning-based software products, transforming technical and clinical data into clear regulatory justifications.
- Design and implement regulatory pathways for launching new products and updating existing software, serving as the internal expert on FDA’s AI/ML regulatory framework and advising on validation and monitoring of adaptive algorithms.
- Engage in design reviews and change control processes to evaluate the regulatory implications of software modifications, particularly updates to AI models and retraining systems, determining when new submissions or internal notifications are required.
- Support the Quality Management System by integrating regulatory requirements like 21 CFR 820 and ISO 13485 into company procedures and representing regulatory interests during audits conducted by the FDA or ISO bodies.
- Evaluate and authorize product labeling, promotional content, and user documentation to confirm that all claims are supported by evidence and align with approved uses.
- Collaborate with Quality teams to track AI model performance after release, lead complaint investigations for potential regulatory reporting (e.g., electronic Medical Device Reports), and oversee recalls or corrective field actions when necessary.
- Train engineering and technical staff on regulatory fundamentals, clarifying submission expectations and demonstrating how development practices contribute to regulatory success.
Inclusive healthcare and benefits
Comprehensive health benefits include medical, dental, and vision coverage, with additional support for gender-affirming care, family planning, fertility services, and travel reimbursement when local healthcare access is limited.
Planning for the future
Employees can participate in a traditional or Roth 401(k) plan with a 2% company contribution to support long-term financial planning.
Modern life stipends
Workers receive stipends to support personal growth, learning, and professional development activities.
Equal Opportunity Employer
The organization is committed to equal employment opportunity and does not tolerate discrimination or harassment based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, veteran status, disability, pregnancy, or other legally protected characteristics.
Criminal Histories
Candidates are evaluated based on qualifications, regardless of criminal history, in accordance with applicable laws.
Reasonable Accommodations
Accommodations are available for candidates with disabilities; individuals needing assistance should contact their recruiter to request support.
Beware of Phishing Attempts
Job seekers should be cautious of phishing scams involving fake offers from fraudsters impersonating company staff. The company will never request financial information during hiring and only uses official '@hingehealth.com' email addresses. Suspicious communications should be reported and can be verified by forwarding to security@hingehealth.com.
