Director, Quality and Regulatory Affairs
Hinge Health
This job is no longer accepting applications
See open jobs at Hinge Health.See open jobs similar to "Director, Quality and Regulatory Affairs" Duke Capital Partners.Legal, Quality Assurance
Portland, OR, USA · San Francisco, CA, USA
Posted on Thursday, December 21, 2023
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, 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 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/week.
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.
About Hinge Health:
LinkedIn recently named Hinge Health one of the Top 50 Startups. Forbes, Fast Company, and Inc. have also recognized our technology, innovation, and culture.
Since our founding in 2014, we've raised more than $800 million from leading investors, including Coatue and Tiger Global. We work with 1000 customers across every industry and the public sector — including Salesforce, Verizon, and the State of New Jersey — to give more than 23 million people access to the care they need. We’re positioned to continue leading the market with unmatched investments in clinical research, care innovation, machine learning, AI, and computer vision.
Diversity and Inclusion:
We’re committed to building diverse teams that reflect the communities we serve. Visit hingehealth.com/diversity-equity-and-inclusion to learn more about what moves us.
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.
By providing your information through this page or applying for a job at Hinge Health, you acknowledge that Hinge Health will collect, use, and process your information as part of our job application process. For more information on how Hinge Health processes your personal information, click here to view our Applicant and Personnel Privacy Notice.
Disclaimer:
There continues to be a significant increase in phishing attempts across all industries where fraudsters are impersonating real employees and sending fictitious job offers to applicants in a scheme to obtain sensitive information. Please note that we will never ask for your financial information at any part of the interview process including the post-offer stage, and will only correspond through @hingehealth.com domain email addresses.
If you encounter any suspicious activity, we recommend you cease all communication with the individual and consider reporting them to the U.S. FBI Internet Crime Complaint Center. If you would like to verify the legitimacy of an email you received from our recruiting team, please forward it to security@hingehealth.com
*Please do not send resumes via email*
This job is no longer accepting applications
See open jobs at Hinge Health.See open jobs similar to "Director, Quality and Regulatory Affairs" Duke Capital Partners.