- BD (Becton, Dickinson and Company) (San Diego, CA)
- **Job Description Summary** As Staff Regulatory Affairs Specialist, you will be responsible for supporting MMS Dispensing products consisting of Medical ... Software and Accessories on a global basis from a Regulatory Affairs standpoint. Support will consist of...Support the monitoring and interpreting of current and new regulatory requirements and international standards for US… more
- Medtronic (Santa Rosa, CA)
- …members, cross functional members at varying levels within the organization as well as International Regulatory Affairs staff . Strategic direction is ... activities/needs as they arise. **Role and Responsibilities** + Works with OU Regulatory Affairs management and staff to build and/ or increase knowledge… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …become your best self. Become a **maker of possible** with us. **Job Overview** As a Staff Regulatory Affairs Specialist, you will play a crucial role in ... Support the monitoring and interpretation of current and new regulatory requirements and international standards for the...QMS requirements are followed and executed consistently from a Regulatory Affairs perspective. + Support efforts for… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- **Job Description Summary** As Staff Specialist Regulatory Affairs , you will have a deep understanding of Risk Based frameworks, Agile SDLC, experience with ... **About You:** + This position is specifically focused on regulatory affairs for Software as a Medical...Guidance + Other SaMD-related guidance documents + Knowledge of international regulatory requirements (FDA QSR, ISO 13485,… more
- GRAIL (Menlo Park, CA)
- …to project teams and leadership. They may manage and provide direction to regulatory staff and, when required, participate in senior management meetings as ... FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such... regulatory approval. + Monitor and report on international regulatory developments and LDT requirements that… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …products to international geographies, providing guidance and advice on international regulatory requirements, providing oversight to and preparation of ... and communicate appropriately quantified risks and mitigation strategies associated with international regulatory strategies to stakeholders. + Write and update… more
- Abbott (Sylmar, CA)
- …device and Cardiac Rythm Management solutions The Opportunity - We are seeking a Regulatory Affairs Project Manager to join our Cardiac Rythm Management team in ... Sylmar CA. As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine knowledge of scientific, regulatory and business… more
- Sumitomo Pharma (Sacramento, CA)
- …highly motivated, and experienced individual for the position of Vice President, Regulatory Affairs , Biopharma R&D. This position leads the Regulatory ... Duties and Responsibilities** **_Regulatory Strategy_** + Develop and Manage Regulatory Affairs Strategy + Develop and gain...**_Manage and Develop Talent_** + Inspire and lead RA staff to ensure attainment of established goals and objectives… more
- Abbott (Santa Clara, CA)
- …imaging catheters and software, vessel closure devices and peripheral stents. This ** Regulatory Affairs Manager** position is an onsite opportunity working out ... regulatory requirements to development and manufacturing teams + Prepare robust regulatory applications (FDA and international regulatory agencies) to… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …and become your best self. Become a **maker of possible** with us. The Sr. Director, Regulatory Affairs is the ranking Regulatory Affairs leader for the ... regulatory leadership for programs in the domestic and international space + Provides strategic guidance to ensure alignment...business partners, provides input into the budget process for Regulatory Affairs + Represents the Platform in… more
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