Director, Quality and Regulatory Affairs

Posted 12.20.23
Location
Remote
Hinge Health is creating a new health care system, built around you. Accessible to 26 million members across 1,500 customers, Hinge Health is the #1 digital clinic for joint and muscle pain, delivering superior member outcomes and proven claims reductions. We pair the industry’s most advanced motion technology and wearable pain relief with a complete clinical care team of physical therapists, physicians, and board-certified health coaches to help people move beyond pain and reduce surgeries and opioid use. Hinge Health’s HingeConnect integrates with 1 million+ in-person providers to enable earlier interventions for avoidable MSK surgeries. Four in five health plans and employers with a digital MSK solution trust Hinge Health, including Land O’Lakes, L.L. Bean, Salesforce, Self-Insured Schools of California, Southern Company, State of New Jersey, US Foods, and Verizon. Learn more at http://www.hingehealth.com
Here at Hinge Health, we welcome all applicants and know a diverse team makes us better and stronger. We look for individuals who embody our leadership principles and we value varied experiences and skill sets. Beyond specific work experience, we also look for unique capabilities and skill sets that are key indicators an applicant will thrive in our fast-paced, frequently evolving environment. If this sounds like the kind of place you’d like to be part of, please apply – we would love to hear from you!
Hinge Health Hybrid Model:
We believe that remote work and in-person work have their own advantages and disadvantages, and want to be able to leverage the best of both worlds. Some roles which require a greater degree of day-to-day collaboration will benefit from more in-person opportunities. Employees in Hybrid roles are expected to be in office 1 day/week (Wednesdays) in hub locations that have an office, and may be expanded to 2 days in 2024.
About the Role
In this role as the Director of Quality and Regulatory Affairs, you will have responsibility for leading Quality Management System (QMS) initiatives that are intended to expand both the patient and geographic reach of Hinge Health’s medical device portfolio. This Director will lead all elements of the Quality Management System for Hinge Health. You will be responsible for creating and executing on the strategies that lead to a high-performing and compliant Quality System, including on-time Regulatory submission strategies and approvals. 
WHAT YOU’LL ACCOMPLISH
  • Responsible for driving and fostering a high-performing and compliant medical device culture at Hinge Health
  • Establishing annual and quarterly quality/regulatory goals and objectives and develops strategies and tactics to deliver associated results. 
  • Plan, lead, and execute all Hinge Health internal and external audits
  • Lead the design, management, and implementation of 510k submission and update processes with both internal and external resources
  • Oversee all elements of the Quality Management System including, but not limited to, Design Controls, Training, Document Control, CAPA, NCMR, Complaints, and Risk Management
WHAT WE’RE LOOKING FOR
  • 10+ years of experience in medical device Quality and/or Regulatory Affairs
  • 5+ years of leading a Quality Management System
  • Previous regulatory affairs experience creating and executing a submission strategy including the 510k process and indication expansion(s)
  • Experience with creating processes that are compliant with 21 CFR 820 and ISO 13485
  • Strong ability and desire to engage, coach, and teach cross-functional team members regarding Quality System and medical device requirements
  • Familiarity with international regulations and new market entry
  • Bachelor’s or master’s degree in an engineering or other STEM discipline
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 budget, use the mental health to support therapy costs, and lifestyle stipends to cover your favorite wellness services, and work-from-home equipment.
  • Flexible vacation and paid time off: Employees have flexibility to choose when, how, and why they take time off to rest and recharge. Exempt employees can take advantage of our flexible pto program. Nonexempt employees can utilize up to two weeks of sick time and up to 17 days of vacation per year, including mental health days.
  • In Office Perks: Daily lunch, coffee/tea and office snacks, and weekly social hours.
  • Other compensation: At Hinge Health, we want every employee to be invested and rewarded in the future success of the company. All full-time positions are eligible for equity.
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