- Twist BioScience (South San Francisco, CA)
- The Regulatory Operations Specialist is responsible for ensuring the efficient and compliant management of regulatory documentation, with a primary focus on ... labeling, and SOP's. This role is crucial in supporting global product compliance , ensuring that all documentation accurately reflects regulatory requirements… more
- Aequor (Thousand Oaks, CA)
- …of DP technical process, manufacturing operations, scientific method, basic regulatory compliance expectations, and quantitative / analytical troubleshooting ... and senior leadership team. Additional Responsibilities include: Engaging with Quality and Regulatory teams to ensure alignment and compliance across the network… more
- Eisai, Inc (San Jose, CA)
- …approved promotional clinical trials, patient access to medication, and regulatory / compliance guidelines preferred.Experience with account planning and ... profile, we want to hear from you. The Senior Oncology Sales Specialist is responsible for meeting/exceeding sales goals through promoting Oncology therapeutic… more
- Merck & Co. (South San Francisco, CA)
- …AI (GenAI) to enhance document authoring processes, thereby improving efficiency and compliance in regulatory submissions.The candidate will play a key role ... to streamline the creation and quality control (QC) of regulatory submission documents. The candidate will be part of...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Abbott (Santa Clara, CA)
- …communicate submission and approval requirements. Participate in risk-benefit analysis for regulatory compliance . Premarket: Assess the acceptability of quality, ... catheters and software, vessel closure devices and peripheral stents. This Senior Regulatory Affairs Specialist position is an onsite opportunity working out… more
- BioTalent (Carlsbad, CA)
- …Senior Regulatory Affairs Specialist to support global regulatory submissions and compliance initiatives. If you're passionate about navigating ... system changes (ECOs, MCOs, NCMRs, SDRs). Drive process improvements and ensure compliance across regulatory processes. Lead Health Hazard Evaluations for… more
- Intuitive (Sunnyvale, CA)
- …[Sr. Regulatory Engineer] or in a Science field (preferable) [Sr. Regulatory Specialist ] Experience: Minimum 5 years relevant experience working in a ... assessing the impact of clinical strategy and design inputs and outputs on regulatory filings and compliance . Create awareness within the organization regarding… more
- Katalyst HealthCares and Life Sciences (Alameda, CA)
- Responsibilities: Responsibilities include developing regulatory strategies, reviewing design input/output documentation, identification of applicable standards and ... guidance documents, performing regulatory assessments to determine the impact of design/process changes,...with IEC 62304, ISO 13485, and FDA Part 11 compliance for software validation. Experience with EU MDR requirements… more
- Raytheon Technologies (Fairfield, CA)
- …we continue to lead the way in safety culture, environmental excellence, and regulatory compliance . As an employee at Collins Aerospace-Fairfield, Safety is an ... Security Clearance: None/Not Required Collins is looking for an Environmental Compliance Principal Specialist who will work onsite in Fairfield,… more
- BioTalent (Westlake Village, CA)
- Senior Regulatory Specialist In your role as a Sr. Regulatory Specialist , you will develop and implement medical device regulatory strategies to ... and provide regulatory input and guidance to cross-functional partners for regulatory documentation for medical device approvals in compliance with EU MDR,… more
