About the Role The Staff Hardware Regulatory Engineer role at Hinge Health is a high-impact position that ensures our cutting-edge medical devices meet global regulatory and quality standards. In this dynamic role, you will spearhead the development, implementation, and maintenance of robust quality assurance programs. You will also manage regulatory submissions and audits, working closely with both internal teams and external regulatory bodies to support product development and lifecycle management. This includes direct collaboration with regulatory agencies. The ideal candidate will possess excellent project management skills and thrive in a collaborative environment, driving innovation and compliance to deliver top-tier medical solutions. What You’ll Accomplish Regulatory Affairs: Develop and implement regulatory strategies to achieve timely product approvals in target markets (e.g., FDA, MDR, etc.) Prepare, review, and submit regulatory documentation including 510(k), CE marking, and other global submissions Maintain up-to-date knowledge of regulatory requirements for medical devices Interface with regulatory authorities during audits, inspections, and inquiries Collaborate with R&D, engineering, and manufacturing teams to ensure product designs meet regulatory requirements Quality Assurance: Develop, implement, and maintain Quality Management System (QMS) compliant with ISO 13485and other relevant standards Oversee internal and external audits to ensure compliance Manage CAPA (Corrective and Preventive Actions) processes to resolve product quality issues Establish and maintain document control procedures to manage records effectively Develop training programs to ensure staff understanding of quality and regulatory requirements Hinge Health Hybrid Model We believe that remote work and in-person work have their own advantages and disadvantages, and we want to be able to leverage the best of both worlds. Employees in hybrid roles are required to be in the office 3 days per week, for the full 8 hours of a typical business day. The San Francisco office has a dog-friendly workplace program. By submitting your application you are acknowledging we are using your personal data as outlined in the personnel and candidate privacy policy. Basic Qualifications: Bachelor’s degree (or equivalent) in Engineering, Life Sciences or related field 8+ years of professional experience in regulatory affairs and/or quality assurance Professional experience with FDA, EU MDR, ISO 13485 or other international medical device regulations Preferred Qualifications: RAC (Regulatory Affairs Certification) or similar credential. Proficient technical writing and documentation skills Compensation This position will have an annual salary, plus equity and benefits. Please note the annual salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. The annual salary range for this position is $144,000 - $216,000. About Hinge Health Hinge Health is moving people beyond pain by transforming the way it is treated and prevented. Connecting people digitally and in-person with expert clinical care, we combine advanced technology, AI and a care team of experts to guide people through personalized care directly from their phone. Our approach is proven to reduce pain by 68%, prevent 42% of new opioid prescriptions, and avoid more than half of joint replacement surgeries. Available to 18M people, Hinge Health is trusted by leading health plans and employers, including Land O’Lakes, L.L. Bean, Salesforce, Self-Insured Schools of California, Southern Company, City of Boston, US Foods, and Verizon. Learn more at http://www.hingehealth.com What You'll Love About Us Inclusive healthcare and benefits: On top of comprehensive medical, dental, and vision coverage, we offer employees and their family members help with gender-affirming care, tools for family and fertility planning, and travel reimbursements if healthcare isn’t available where you live. Planning for the future: Start saving for the future with our traditional or Roth 401k retirement plan options which include a 2% company match. Modern life stipends: Manage your own learning and development Diversity and Inclusion Hinge Health is an equal opportunity employer and prohibits discrimination and harassment of any kind. We make employment decisions without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, age, veteran status, disability status, pregnancy, or any other basis protected by federal, state or local law. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. We provide reasonable accommodations for candidates with disabilities. If you feel you need assistance or an accommodation due to a disability, let us know by reaching out to your recruiter. Workday ID JR1391