- Participate as the regulatory representative supporting cross-functional project teams.
- Draft and execute regulatory strategies for new product development and device modifications, including identifying regulatory risks, tracking timelines and submission deliverables, and establishing contingency plans.
- Support RA functional area in the review and approval of change orders, including writing letters to file where applicable.
- Obtain market clearance and approvals for class I and II medical devices, including (but not limited) to 510(k)s, IDEs, pre-submissions and PMAs.
- 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.
- 6+ years of leading strategic Regulatory initiatives within a medical device organization
- Experience preparing domestic and international product submissions
- Experience with creating processes, from scratch or significantly updated, 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
- Familiarity with international regulations and new market entry
- Bachelor's or master's degree in an engineering or other STEM discipline
- 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 $144,000 - $216,000 a yearConsider the range above plus equity, and benefits. Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies and work location.
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Regulatory Affairs Manager - San Francisco, United States - Hinge Health
Description
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, Bean, Salesforce, Self-Insured Schools of California, Southern Company, State of New Jersey, US Foods, and Verizon.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 youLearn more at 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 a Regulatory Affairs Specialist, you will have responsibility for developing and influencing regulatory policy and determining and pursuing courses of action necessary to obtain and expand regulatory approval of Hinge Health's medical device portfolio. This Specialist will work with internal and 3rd party experts to set strategy for regulatory approval to introduce new products to market, provide advice on regulatory requirements and prepare regulatory submissions.WHAT YOU'LL ACCOMPLISH
BASIC QUALIFICATIONS
PREFERRED QUALIFICATIONS
WHAT YOU'LL LOVE ABOUT US
