- Actalent (San Diego, CA)
- …of new and revised labeling. Required Skills: + Experience in medical device labeling and regulatory compliance + Proficiency in graphic design ... labeling process for both new and existing in vitro diagnostic (IVD) and medical device (MD) products. This role requires cross-functional collaboration to… more
- AbbVie (Irvine, CA)
- …works with internal and external partners to deliver products to patients. Prepares device regulatory strategies that enable first pass approvals. Develops and ... influence, and provide strategic advice. Additional Responsibilities Include: + Prepares device regulatory product strategies. Prepares and manages regulatory… more
- Fujifilm (Sacramento, CA)
- …to Division General Counsel and senior business management on general legal and regulatory risks affecting the Medical Device businesses, including with ... part of the legal team providing support to the Medical Device businesses of FUJIFILM Healthcare Americas...respect to healthcare regulatory compliance , anti-kickback statutes, the False Claims Act, US government… more
- AbbVie (Irvine, CA)
- …with FDA's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ... that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a...our talent pipeline and considered for future opportunities. The Device Engineer will work collaboratively with a team to… more
- AbbVie (Pleasanton, CA)
- …with FDA's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ... our talent pipeline and considered for future opportunities. The Device Engineer will work collaboratively with a team to...work collaboratively with a team to design and develop medical products from initial concept through the transfer to… more
- Danaher Corporation (West Sacramento, CA)
- …budget overruns. + Utilize project management tools to track progress and ensure compliance with internal policies. The essential requirements of the job include: + ... pay. We offer comprehensive package of benefits including paid time off, medical /dental/vision insurance and 401(k) to eligible employees. Note: No amount of pay… more
- Oura (San Francisco, CA)
- …Regulation (QSR) and Good Manufacturing Practices (GMPs), as well as post-market compliance , including Medical Device Reporting (MDR), product recalls, ... at local co-working locations. The AGC, Senior Director of Regulatory Compliance & Privacy will provide strategic...wearable devices and related software, including Software as a Medical Device (SaMD), Software in a … more
- Caldera Medical (Westlake Village, CA)
- …regulatory input and guidance to cross-functional partners regulatory documentation for medical device approvals in compliance with EU MDR, MDSAP, ... your role as a Sr. Regulatory specialist, you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide … more
- Kelly Services (Irvine, CA)
- ** REGULATORY COMPLIANCE - SENIOR ANALYST (Hybrid)** QUALIFICATIONS: a) Minimum education required: * A Bachelor's degree is required, preferably in a science or ... experience in a Quality, Manufacturing or Engineering function in medical device industry * At least 5...meetings. * Participates in the formulation of Policies and Regulatory Procedures in compliance with the standards… more
- Meta (Sunnyvale, CA)
- **Summary:** As a Hardware Regulatory Readiness and Compliance Technical Program Manager at Meta, you will play a critical role in crafting our compliance ... in delivering high-quality products that meet customer needs while ensuring compliance with regulatory requirements. **Required Skills:** Technical Program… more