Full-Time

Regulatory Affairs Manager

Posted on 5/15/2024

Hinge Health

Hinge Health

1,001-5,000 employees

Digital clinic for muscle and joint pain


Senior

San Francisco, CA, USA

Requirements
  • 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
Responsibilities
  • Participate as the regulatory representative supporting cross-functional project teams
  • Draft and execute regulatory strategies for new product development and device modifications
  • Obtain market clearance and approvals for class I and II medical devices
  • Interact with regulatory agency authorities for initial submission and query resolution
  • Support quality system changes, improvements and audits as needed
  • Develop and maintain regulatory procedures

Hinge Health offers a digital clinic for joint and muscle pain, leveraging advanced motion technology and wearable pain relief. Their HingeConnect platform integrates with over 1 million in-person providers to enable earlier interventions for avoidable MSK surgeries.

Company Stage

Series E

Total Funding

$1.2B

Headquarters

San Francisco, California

Founded

2014

Growth & Insights
Headcount

6 month growth

8%

1 year growth

20%

2 year growth

45%

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