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Alameda Health System
Oakland, CA, United States
Summary SUMMARY: Plans, coordinates, monitors compliance with federal, state and local regulations; manages accreditation activities necessary for maintaining required accreditation; manages requirements for certifications and licensure from various organizations, such as Joint Commission (JC), California Department of Public Health (CDPH), CMS,
Job Source: Alameda Health SystemAbbVie
South San Francisco, CA, United States
Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and serv
Job Source: AbbVieHinge Health
San Francisco, CA, United States
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 4
Job Source: Hinge HealthAlameda Health System
Hercules, CA, United States
Summary SUMMARY: Plans, coordinates, monitors compliance with federal, state and local regulations; manages accreditation activities necessary for maintaining required accreditation; manages requirements for certifications and licensure from various organizations, such as Joint Commission (JC), California Department of Public Health (CDPH), CMS, O
Job Source: Alameda Health SystemAlameda Health System
Castro Valley, CA, United States
Summary SUMMARY: Plans, coordinates, monitors compliance with federal, state and local regulations; manages accreditation activities necessary for maintaining required accreditation; manages requirements for certifications and licensure from various organizations, such as Joint Commission (JC), California Department of Public Health (CDPH), CMS, O
Job Source: Alameda Health SystemHinge-Health
San Francisco, CA, United States
Overview: 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 Healths medical device portfolio. This Specialist will work with internal and 3rd party exp
Job Source: Hinge-HealthMastech Digital
Oakland, CA, United States
Position: HIM Director-Regulatory Affairs Manager Location: Oakland CA USA 94612 (5 days onsite) Duration: 12+ Months (Possibility to extend/Convert) Required Qualifications: ? Bachelor's degree with additional 10 years of progressively responsible experience managing quality compliance/assurance functions. Masters degree may substitute for two
Job Source: Mastech DigitalAlameda Health System
Daly City, CA, United States
Summary SUMMARY: Plans, coordinates, monitors compliance with federal, state and local regulations; manages accreditation activities necessary for maintaining required accreditation; manages requirements for certifications and licensure from various organizations, such as Joint Commission (JC), California Department of Public Health (CDPH), CMS, O
Job Source: Alameda Health SystemSan Francisco, CA, United States
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, City of Boston, US Foods, Toyota, 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 you!
Learn more at http://www.hingehealth.com
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
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.
BASIC QUALIFICATIONS
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
PREFERRED QUALIFICATIONS
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
$144,000 - $216,000 a year
Consider 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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Email Alert for Regulatory Affairs Manager jobs in San Francisco, CA, United States
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