- Praxair, Inc - a Linde Company (Fresno, CA)
- …- $112,200 yearly (commensurate with experience) What you will be doing: + Provide FDA regulatory and Quality systems support to assigned locations within ... Quality personnel to ensure Manufacturing and Warehousing locations meet or exceed FDA and corporate Quality requirements. This employee will ensure … more
- Oura (San Francisco, CA)
- …privacy and regulatory compliance with commercial objectives. What you will do: FDA & Global Regulatory Compliance: + Serve as the primary legal advisor ... risk for wearable-based health technology. + Provide strategic counsel on FDA oversight, regulatory submissions, and compliance strategies for biometric… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …execute comprehensive regulatory strategies for SaMD products in alignment with FDA regulations and guidance documents. + Provide regulatory input during the ... including evaluation of cybersecurity risks. + Collaborate with R&D, Quality , Marketing, and Regulatory teams to ensure...Guidance and SaMD related Guidance. + Knowledge of international regulatory requirements (eg, FDA QSR, ISO 13485,… more
- Oura (San Francisco, CA)
- …best work - both in and out of the office. We are looking for a Director, Regulatory Affairs and Quality Assurance to play a key role in shaping Oura's future ... products and services. What you will do: + Lead regulatory and quality strategy for product development,...management for all regulated features. + Ensure compliance with FDA , CE (MDR), and other relevant global regulatory… more
- Abbott (Santa Clara, CA)
- …software, cybersecurity, telehealth, etc.) have targeted mitigations to align with FDA expectations, ensuring high- quality submissions and predictability for ... + Communicates with internal groups to share updates on regulatory changes as it pertains to the FDA + Utilizes technical regulatory skills to proposed… more
- Kelly Services (Anaheim, CA)
- **Director of Quality and Regulatory Affairs** Kelly(R) Science & Clinical is seeking a **Director of Quality and Regulatory Affairs** for a ... In this role, you will be responsible for developing, coordinating, and implementing quality and regulatory strategies and programs required for the development,… more
- Abbott (Alameda, CA)
- …product post-marketing approval requirements as needed. **Core Responsibilities** + Prepares robust regulatory applications (either for FDA or for international ... help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with...communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA… more
- Abbott (Santa Clara, CA)
- …trial operations and product market entry. **What You'll Work On** + Prepares robust regulatory applications (either for FDA or for international regulatory ... communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other… more
- Kelly Services (Petaluma, CA)
- …a ** Regulatory Engineering Specialist** who can bridge the gap between engineering, quality , and regulatory functions. This role is ideal for someone who ... ** Regulatory Engineering Specialist** **Location:** Petaluma, CA (Onsite) **Employment...oversight. **What You'll Do** + Partner with engineering and quality teams to ensure FDA compliance on… more
- Kelly Services (Valencia, CA)
- … regulatory programs across two facilities. **Key Responsibilities:** + Oversee regulatory submissions ( FDA , EU MDR, international). + Maintain product ... + Prepare/approve procedures, ECOs, and testing documentation. + Support quality training and system improvements. + Supervise and develop...+ Proven experience with 5 years or more of FDA submissions and international regulatory compliance. +… more
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