- Chemours (Sacramento, CA)
- …Engineering, Biological Science, Toxicology or comparable technical field + 5+ years of medical device regulatory compliance experience with respect ... outside lawyers, consultants, industry associations, and local agencies on specific medical regulatory topics. + Coordinate and review customer… 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 (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
- 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
- J&J Family of Companies (Santa Clara, CA)
- …States of America **Job Description:** Johnson & Johnson is hiring for a **Sr. Manager, Regulatory Compliance - Shockwave Medical ** to join our team located ... aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease...for the treatment of calcified plaque. **JOB SUMMARY** The Regulatory Compliance Senior Manager provides key strategic… more
- Capgemini (Pleasanton, CA)
- …in the medical technology industry. + Deep understanding of medical device software verification and regulatory compliance (FDA, ISO 13485, IEC ... the quality, reliability, and performance of web portals used in the medical industry. You'll collaborate with cross-functional teams to develop and execute test… more
- J&J Family of Companies (Irvine, CA)
- …Degree is preferred. + A minimum of 8 years of combined experience in Regulatory Compliance and/or Quality in Medical Devices or pharmaceutical products ... & Johnson is currently seeking a Senior Manager, Source Regulatory Compliance to join our Regulatory...is required. Medical Device experience is preferred. + Strong knowledge of FDA… more
- Abbott (Alameda, CA)
- …submission and approval requirements. + Participate in risk benefit analysis for regulatory compliance . + Assess the acceptability of documentation for gap ... changes. + Participate in risk benefit analysis for regulatory compliance . + Monitor impact of changing...work experience + Minimum 8 years' experience in the medical device industry, with 5 of those… 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
- J&J Family of Companies (Santa Clara, CA)
- …assigned. **Requirements** + Minimum 5 years of regulatory affairs experience in the medical device industry with a Bachelor's degree; or 3 years and a ... aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease...+ Evaluate proposed design, clinical and manufacturing changes for regulatory impact and approve changes in compliance … more