Regulatory Affairs Manager: Average Salary in Pleasanton, CA in 2024

Submits product labeling in compliance with legal/regulatory requirements and communicates planned/approved changes with operations, commercial, medical affairs and marketing. Has recognized regulatory expertise and extensive knowledge of regulatory requirements and regulations with ability to strat...

Manager in Regulatory Affairs is responsible for developing and managing regulatory strategies to remain compliant with U. Extensive knowledge of regulatory requirements, including ICH and regional requirements and an understanding of current global and regional trends in regulatory affairs. FDA and...

As an International Regulatory Project Manager you will be a member of CDx International CDx within the International Regulatory Chapter. Provide input to project and product regulatory strategy based on international regulatory requirements and support international regulatory submissions by provis...

As an International Regulatory Project Manager, you will be a member of CDx International CDx within the International Regulatory Chapter. Provide input to project and product regulatory strategy based on international regulatory requirements and support international regulatory submissions by provi...

Submits product labeling in compliance with legal/regulatory requirements and communicates planned/approved changes with operations, commercial, medical affairs and marketing. Has recognized regulatory expertise and extensive knowledge of regulatory requirements and regulations with ability to strat...

Liaise with colleagues in Regulatory Affairs therapeutics teams, company local Affiliates, Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines. Senior Manager, Regulatory Affairs III. Sen...

Alternative Education and Experience Requirement: Bachelor’s degree in Medical Device and Diagnostics Engineering, Regulatory Affairs/Compliance, Biology, Chemistry, or related field of study plus 8 years of experience in IVD Regulatory Affairs or Medical Device Regulatory Affairs as a Regulatory Af...

Submits product labeling in compliance with legal/regulatory requirements and communicates planned/approved changes with operations, commercial, medical affairs and marketing. Has recognized regulatory expertise and extensive knowledge of regulatory requirements and regulations with ability to strat...

Prepare and coordinate the compilation and/or submission of documents to regulatory agencies in supp. ...

The Senior Compliance Analyst has advanced knowledge of the job area and technical systems and practices, and advanced technical skills and reporting abilities. Maintains the compliance FWA audit program, including schedules, standards, processes, reports and tools in close collaboration with Compli...

Responsible for reporting monthly adjustments and corrections to the Compliance Manager. ...

Regulatory Affairs Associate I. A Master's Degree in Regulatory Affairs with a minimum of 3 months of regulatory experience (internship) is required. Help determine regulatory strategies for manufacturing changes and regulatory activities. Coordinate and track workflows for regulatory submissions. ...

The successful candidate will partner with internal and external stakeholders, including vendors and third-party assessment organizations (3PAOs), to ensure remediation is completed, controls are implemented and documented in accordance with FedRAMP compliance standards, and SLAs are met. Perform co...

Project Manager provides guidance and support to the field service team during installation and start-up. Monitor and analyze project costs to provide recommendations for future projects. Set up and maintain project sales orders and budgets using SAP. Proficient in Microsoft Systems (Outlook, Excel,...

Director of Regulatory Affairs Body Contouring and Regulatory Innovation MPS. Directs and supports development of the regulatory strategy related to MPS activities for device regulatory activities in a variety of counties including but not limited to US, EU, US, Japan, and China. Supports regulator...

The Clinical Program Manager in Clinical Operations Study Management will be responsible for overseeing the execution of clinical trials in oncology and other therapeutic areas, as required. At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous ...

Our team members are highly knowledgeable and have diverse backgrounds in tax compliance, including tax technical compliance and reporting requirements, Pillar II compliance, process and technology enhancement, advanced calculations, and compliance and reporting for inbound and outbound businesses. ...

Assist in the preparation of regulatory submissions in support of IVDR implementation of Toxicology and Therapeutic Drug Monitoring Assays. Organize and assist in the review of materials for inclusion in regulatory submissions both in the EU and worldwide. Support the preparation of dossiers and sub...

Develop and maintain project plans, schedules, and resource allocation to ensure timely and efficient project execution. Previous experience with leading software modernization efforts as a technical project manager. Monitor and report on project status, identifying and mitigating risks and issues a...

The Environmental Compliance Specialist is responsible for coding environmental commitments from environmental and permit approval documents into the Authority's Environmental Management and Mitigation Assessment database application (EMMA), preparing reports in EMMA to identify gaps and document mi...

As an individual contributor, this position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Prepares robust ...

This **Regulatory Affairs Specialist** **II** will work out of our Pleasanton, CA location in our Heart Failure Division. As an individual contributor, this position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwid...

As a Technical Program Manager at Lam, you are not just overseeing projects – you’re orchestrating breakthroughs in support of developing and releasing new products. Global Operations - NPI Materials, Technical Program Management, brings information systems, facilities, supply chain, logistics, and ...

As an experienced individual contributor, a Principal Regulatory Affairs Specialist is to provide support for the regulatory department, ensuring efficient and compliant business processes and environment. Principal Regulatory Affairs Specialist. This position performs specialized level work assignm...

As the Senior Global Regulatory Affairs Specialist, you will be responsible for regulatory activities related to the development and implementation of global regulatory strategies to support the submission, filing, and registration of multiple indications (clinical applications or “apps”) in general...