Full-Time
Regulatory Affairs Manager
Posted on 5/15/2024
Hinge Health
1,001-5,000 employees
Digital clinic for joint and muscle care
No salary listed
San Francisco, CA, USA
Requires onsite presence in San Francisco for three days per week.
Requires onsite presence in San Francisco for three days per week.
Requires onsite presence in San Francisco for three days per week.
| ⚖️Legal & Compliance (2) |
|---|
| , |
- 6+ years of leading strategic Regulatory initiatives within a medical device organization
- Experience preparing domestic and international product submissions
- Experience with creating processes compliant with 21 CFR 820, ISO 13485, ISO 14971
- Experience in the design and development of software as medical device (SaMD) to IEC 62304 and medical electrical devices to IEC 60601
- Ability to engage, coach, and teach cross-functional team members regarding Regulatory Affairs and medical device requirements
- Participate as the regulatory representative supporting cross-functional project teams
- Draft and execute regulatory strategies for new product development and device modifications
- Support RA functional area in the review and approval of change orders
- Obtain market clearance and approvals for class I and II medical devices
- Create and review project deliverables for regulatory submissions
- Interact with regulatory agency authorities for initial submission and query resolution
- Review and approve device labeling and promotional materials
- Support multiple projects simultaneously
- Support quality system changes, improvements and audits as needed
- Develop and maintain regulatory procedures
- Assist in keeping the company informed of current and proposed regulatory requirements
Hinge Health focuses on digital care for joint and muscle health, offering a platform that combines clinical support with technology for personalized physical therapy. The Hinge Health app provides users with exercises, communication with care teams, and educational resources, helping them manage pain and recover from injuries. Unlike competitors, Hinge Health is accessible at no cost through partnerships with over 1,500 employers and health plans. The company's goal is to enhance the quality of care for individuals dealing with joint and muscle issues.
Company Size
1,001-5,000
Company Stage
IPO
Headquarters
San Francisco, California
Founded
2014
Simplify's Take
What believers are saying
- Hinge Health's IPO raised $437 million, indicating strong market interest.
- Partnership with Cigna Healthcare expands access to digital musculoskeletal care.
- AI integration in telemedicine enhances patient outcomes and streamlines processes.
What critics are saying
- Increased competition from similar digital health platforms may erode market share.
- Changes in employer and health plan partnerships could impact revenue.
- Regulatory changes in digital health could impose additional compliance costs.
What makes Hinge Health unique
- Hinge Health combines wearable sensors and computer vision for personalized care.
- The company offers a digital clinic accessible via a single app and wearable technology.
- Hinge Health partners with over 1,500 employers and health plans for cost-free services.
Help us improve and share your feedback! Did you find this helpful?
Benefits
Competitive compensation with meaningful equity
Medical, Dental, Vision, Disability and Life Insurance (We cover 100% of your premium and 75% for your dependents)
Flexible PTO
FSA/HSA accounts
Family & fertility benefit through Maven Clinic
401(k) match
3 months paid parental leave
Professional Development budget
Quarterly lifestyle benefit to use towards WFH equipment & fitness
Generous mental health stipend
Work from home policy
Opportunity to join a fantastically talented, diverse, and passionate team at a pivotal time in the company's lifecycle
Growth & Insights and Company News
6 month growth
↑ 0%1 year growth
↓ -2%2 year growth
↑ 1%Hinge Health and Omada Health have gone public, marking a cautious reopening of the digital health IPO market after a three-year drought. Despite their successful debuts, with Hinge Health's market cap rising over 40% since its May IPO, few digital health startups are expected to follow suit until at least 2026. The preparation for an IPO can take over a year, and many companies are opting for M&A instead. Hinge Health's IPO valuation was $2.6 billion, a 58% markdown from its 2021 private valuation.
Hinge Health, Inc. is thrilled to announce the winners of the 2025 Hinge Health Movement Awards.
Hinge Health, a digital health company specializing in musculoskeletal disorder treatments, went public on the New York Stock Exchange on May 22. Despite a 52% drop in valuation since its Series E funding in 2021, the company's stock rose 17% on its first day, closing with a market cap of $2.9 billion (approximately ¥415.7 billion). This marks a significant moment for the digital health sector, integrating AI and telemedicine to redefine treatment platforms.
Hinge Health, a digital physical therapy company, closed its first day of trading on the New York Stock Exchange on Thursday at $37.56, up about 17% over
Hinge Health Inc., an AI-powered physical therapy startup, raised approximately $437 million in its initial public offering, reaching the top of its range. This IPO was one of two venture-backed offerings, collectively raising over $624 million, both represented by Latham & Watkins LLP.