- AbbVie (South San Francisco, CA)
- …(eg, PSSAP, study SAPs, ISS SAP). + Provide strategic input on safety related submissions to regulatory agencies and responses to requests from regulatory ... team physicians, epidemiologists, safety analysts), Statistical Programming, Clinical Statistics, Regulatory Affairs, and Medical Writing. Safety Statisticians work on… more
- Cordis (Santa Clara, CA)
- … regulatory submission process as a subject matter expert. Supports regulatory by providing technical justifications for submissions , reviewing regulatory ... filings, and answering technical questions during planned meetings. + Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental.… more
- Actalent (Modesto, CA)
- …position at the site, working alongside a nurse lead. Responsibilities + Perform regulatory tasks, including IRB submissions . + Engage in sponsor correspondence, ... Clinical trial management + Good Clinical Practice (GCP) + IRB knowledge + Regulatory experience + Patient recruitment + Data entry proficiency + Electronic Data… more
- Cedars-Sinai (Los Angeles, CA)
- …metrics. + Establishes and leads enterprise strategy for quality-related data submissions to regulatory agencies, clinicalregistries, and payers. + Serves ... as a strategic partner to senior executives, clinical and operational leaders to align data, analytics,and AI capabilities to organizational priorities; represents analytics function in executive-level planning anddecision-making forums. + Directs the creation… more
- BeOne Medicines (San Mateo, CA)
- …+ Ability to work flexible business hours as required to support global submissions within a global Regulatory Operations team. Ability to work beyond ... **General Description:** + This position supports Regulatory Affairs personnel in the coordination, preparation, and...of all INDs/NDAs/MAAs and life cycle management of these submissions in both paper and electronic format to global… more
- Oura (San Francisco, CA)
- … agencies and notified bodies. + Guide the creation and submission of regulatory filings including 510(k)s, De Novo submissions , and international registrations. ... consumer-facing wearables strongly preferred. + Proven track record of successful FDA submissions (510(k), De Novo) and international regulatory approvals. +… more
- City National Bank (Los Angeles, CA)
- … interactions with guidance on best-in-class presentations, materials and other submissions provided to regulators. * Synthesize regulatory feedback and ... * REGULATORY RELATIONS ANALYST* WHAT IS THE OPPORTUNITY? Responsible...for working with Associate Director ("AD") to coordinate end-to-end regulatory activity within CNB and the broader Combined US… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …position is responsible for support of a variety of international related regulatory activities continuous improvement and regulatory projects. This position is ... products to international geographies, providing guidance and advice on international regulatory requirements, providing oversight to and preparation of worldwide … more
- Abbott (Sylmar, CA)
- …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...and SOPs + Experience working with 510k and PMA submissions The base pay for this position is $112,000.00… more
- Amazon (Sunnyvale, CA)
- …tablets, Fire TV, and Echo. What will you help us create? The Sr. Regulatory Compliance Engineer position requires expertise in RF System, EMC Design and Design for ... Regulatory Compliance. The right candidate will be an exemplary...testing, data interpretation and debug experience - Experience in submissions for official certification through relevant compliance bodies such… more