- 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
- 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
- Ascendis Pharma (Palo Alto, CA)
- …role involves engaging closely with internal peers and externally stakeholders such as the FDA , EMA, and other key regulatory bodies. The candidate must not only ... to 30-40 days per year domestically and internationally + Broad experience in Regulatory Affairs, working directly with FDA and international agencies with focus… more
- Abbott (Alameda, CA)
- …on future actions. + Complies with US Food and Drug Administration ( FDA ) and international regulations, other regulatory requirements, Company policies, ... glucose levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager - International Compliance Operations** will work on-site at… 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