- 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
- 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
- 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
- AbbVie (Irvine, CA)
- …and lifecycle management for the assigned medical device or device aspect of combination products. Support regulatory intelligence and policy activities ... Provide regulatory support, project management and leadership for the ( Medical Device Regulation - MDR) implementation globally. Supports due diligence… more
- Stryker (Sacramento, CA)
- Stryker is seeing a ** Regulatory Compliance Specialist** for our Endoscopy (https://www.stryker.com/us/en/endoscopy.html) division. This is a remote role located ... within the US. **What you will do** As the ** Regulatory Compliance Specialist,** you will support post-market...and product holds + Knowledge of FDA and international medical device regulations (eg, 21 CFR Part… more
- Meta (Burlingame, CA)
- …scientific discipline or equivalent work experience 6. 3+ years of industry experience in medical device regulatory affairs or related industry 7. Experience ... a regulatory affairs specialist to join our medical devices compliance team. You will get...get to work on wearables and Software as a Medical Device (SaMD) applications for the US… more