of the role We are currently seeking a highly motivated Regulatory Affairs Specialist to join our Regulatory Affairs department. Qualified individuals will be responsible for collection and coordination of regulatory documentation for submission to regulatory and business partners. Position Responsibilities Assist with the collection, coordination, and preparation of infor

Job Location Los Angeles, Irvine, San Diego , CA Position Type Full Time Education Level Bachelor's Degree   Salary Range $88,538.00 $132,807.00 Salary ESA seeks a highly motivated CEQA Project Manager to join one of our Southern California offices on a hybrid schedule. We are looking for a team member with 5+ years of CEQA experience who is proactive and has the inte

OF ROLE The Senior Complaints Specialist is a key addition to the Quality Assurance team. This role will lead the complaint handling process, MDR reporting, and EU Vigilance processes. Collaborates with cross functional teams to address customer concerns and improve product quality. If you have a proven track record of handling and managing those Quality System elements, w

The candidate selected for this role will Provide legal guidance and counseling to business and functional teams (such as sales and marketing, regulatory affairs, medical affairs, government affairs, patient access, clinical, quality, R&D, finance, and others). Proactively identify and manage regulatory legal risks for complex US or global issues and develop and approve a

The candidate will be responsible for managing the financial support services to the Line of Business, serving as a business partner focal for all finance and accounting, including planning, budget, forecasting, tools, and optimization analysis The successful candidate's team includes program analytical support for high profile Electric programs. Additionally activities i

Develop and implement regulatory strategies to facilitate the progress of programs in all phases of development Serve as the Regulatory Affairs representative on project teams; assure the progress of projects by providing direction, solutions, and feedback to the teams Lead regulatory interactions with health authorities, marketing partners, and vendors for their products

To perform this job successfully, an individual must be able to satisfactorily perform each essential duty listed below. Collect and track all information needed to complete and submit regulatory state and federal reports in a timely manner. Assist in the preparation of regulatory filings, including collection, tracking, and maintenance of all information necessary to com

The Position The Opportunity This Job is an Individual Contributor position. In the position of Regulatory Program Director in Roche / Genentech Pharma Technical Regulatory (PTR), you will be accountable for Health Authority interactions pertaining to CMC Information (i.e. CMC information in an IND, IMPD and NDA/BLA/MAA filings), as well as informational and pre submissio

Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure wave

Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure wave

/JOB PURPOSE Manages all regulatory activities for new development programs, pre IND through BLA/NDA and post approval, with a particular focus on biologics (ADCs, bispecifics, and etc.). Responsible for developing and implementing global regulatory strategies encompassing clinical, non clinical and CMC disciplines, as well as companion diagnostics, as appropriate. Provide

We provide our utility clients with a wide range of energy saving and renewable energy solutions. From individual utility customers and construction contractors, to utilities, municipalities, and government bodies, our clients have come to depend on our customized energy efficiency programs to help them to meet their energy saving goals. The Energy Advisor is primarily fo

Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure wave

The HR Compliance Manager manages essential programs and projects within the department, primarily related to HR compliance, recordkeeping and auditing, the development and execution of the Company's Affirmative Action Program (AAP) and assuring implementation of the Company's equal employment opportunity (EEO) policy. This individual is responsible for independent work d

About the Team WEX is seeking a Regulatory Compliance Analyst to join their growing global Risk and Compliance organization, supporting the overall compliance and risk management program for WEX Health.The successful candidate will act as a resource to assist in the building, support, and maintenance of a consistent and scalable regulatory framework for WEX Health, with a