Regulatory Affairs Specialist Jobs in California

210 jobs

Senior Regulatory Affairs Specialist, Orange County, Medical Device, Regulatory Affairs A major Orange County medical device company is urgently seeking a Senior Regulatory Affairs Specialist. This role will plan and execute global regulatory activities necessary to obtain and maintain regulatory approvals within the domestic and International markets. You will be part of a collaborative and inno...

Regulatory Affairs Specialistsneeded for acontractopportunity with Yoh's client located inBerkeley, CA. The Big Picture - Top Skills You Should Possess: - Minimum five (5) years of direct Regulatory Affairs CMC Biotech experience What You'll Be Doing: - The objective of this job is the identification of the current documentation in the Kogenate US BLA - This will require revision of all docum...

Company Confidential
POSITION SUMMARY: Working with minimal supervision, manage complex projects/products, including responsibility for the content, assembly, pre-final review, and filing of major medical device applications (e.g., IDEs, PMAs, 510(k)s) submitted to the FDA and foreign regulatory agencies. Applies regulatory expertise to the evaluation and solution of product development issues. SPECIFIC DUTIES AND R...

Company Confidential
POSITION SUMMARY: Working with minimal supervision, manage complex projects/products, including responsibility for the content, assembly, pre-final review, and filing of major medical device applications (e.g., IDEs, PMAs, 510(k)s) submitted to the FDA and foreign regulatory agencies. Applies regulatory expertise to the evaluation and solution of product development issues. SPECIFIC DUTIES AND R...

CyberCoders Matching Great People with Great Companies Learn more about CyberCoders Regulatory Affairs Carson, CA; El Segundo, CA Full-Time $50,000 - $90,000 Apply Apply Regulatory Affairs Carson, CA; El Segundo, CA Full-Time $50,000 - $90,000 Apply Job Details If you are a Regulatory Affairs and Compliance Associate with 3+ years of submitting drug master files, please read on! What...

Regulatory Operations and Compliance (ROC) team member in the RA Systems Support Group responsible for supporting account requests, SharePoint maintenance and dictionary management under direct supervision. The incumbent will perform other duties assigned. Manage account requests and verify training as needed Maintain SharePoint sites Update list values for document management system Support t...

CyberCoders Matching Great People with Great Companies Learn more about CyberCoders Sr. Regulatory Affairs Specialist San Jose, CA Full-Time $90,000 - $120,000 Apply Apply Sr. Regulatory Affairs Specialist San Jose, CA Full-Time $90,000 - $120,000 Apply Job Details If you are a Sr. Regulatory Affairs Specialist with experience, please read on! We are located in San Jose, CA and are a...

The position of the Regulatory Affairs Specialist 1 is located in Chatsworth, CA and reports to the Regulatory Manager. It is responsible for the development, retrieval and maintenance of regulatory submissions. This position will work closely with the Manager in the preparation of submissions (notifications & registrations) for new products, product changes, as required to ensure continued compli...

Senior Regulatory Affairs Specialist, San Diego, Medical Device, Spinal A leading spinal company in the San Diego area is seeking a regulatory affairs specialist to support global expansion initiatives by submitting and obtaining regulatory approvals in international markets. This is a direct hire position is available for immediate start. Responsibilities: Prepares and submits international re...

Regulatory Affairs Specialist, San Diego, Medical Device, Cardiovascular A leading cardiovascular medical device company in San Diego is seeking a regulatory affairs specialist to provide support to the Regulatory Affairs Department ensuring compliance with applicable US and international regulations. This is a direct hire position is available for immediate start. Responsibilities: Prepare and...

Regulatory Affairs Specialist, San Diego, Diagnostics, Regulatory Affairs A leading company in tissue-based diagnosis in San Diego, Ca is seeking a strong regulatory affairs specialist to develop and implement programs and processes to support the product development process. This is a direct hire position is available for immediate start. Responsibilities: Provide regulatory support for curren...

Regulatory Affairs Specialist, San Diego, Medical Device, Regulatory Affairs A cutting edge cardiovascular start-up in San Diego is seeking a strong regulatory affairs specialist to coordinate the overall regulatory submission process and develop a company strategy for regulatory approvals to support the product development process. This is a direct hire position available for immediate start. R...

Regulatory Affairs Specialist, P/T, Flexible Hours NOTE: Corrected email address below DiamoDent, Inc. is a dental manufacturer located in Anaheim seeking for a part time Regulatory Affairs Specialist with strong organization and communication skills. The ideal candidate must have minimum of 5 years experience with FDA Quality regulations, ISO 13485, and CMDCAS. Must have experience in establish...

Cordis Corporation: Regulatory Affairs Specialist I-5107150728DescriptionJohnson & Johnson has agreed to sell Cordis Corporation to Cardinal Health subject to customary closing conditions and regulatory approvals. This transaction is anticipated to close later this year (2015). Upon completion of the transfer, your employment with Cordis Corporation will transfer to Cardinal Health according to lo...

Allergan is seeking for a Senior Specialist, Regulatory Affairs. This position will be located in Irvine, CA. On March 17, 2015, Actavis completed the acquisition of Allergan, creating a $23 billion diversified global pharmaceutical company and a leader in a new industry model - Growth Pharma. The combined company is anchored by strong and sustainable brand franchises, a leading global generics b...

Position Description The position requires a person with energy, commitment to excellence, and ability to work in a fast-paced, technically skilled, team setting. Responsible for coordinating and preparing document packages for regulatory submissions from all areas of company, internal audits and inspections. Compiles all materials required in submissions, license renewal and annual registrations...

Regulatory Affairs Specialist IV-4352150722 Description Cardiovascular Specialty Solutions Group (CSS) Group, a Family of Companies within Johnson & Johnson, is recruiting for a Regulatory Affairs Specialist IV, located in Irvine, CA. Cardiovascular Specialty Solutions Group (CSS) Group is combining ASP, Acclarent, Biosense Webster and Mentor into a single business unit, single global managemen...

Would you like to be part of a dynamic organization who enable health care professionals to improve the lives of their patients in ophthalmology, microsurgery and other medical growth sectors? The Senior Regulatory Affairs Specialist is responsible for US and international medical device premarket and post market activities for assigned products. Products include software driven electrical medica...

Mizuho OSI is a U.S. based company founded over 30 years ago and the leader in the specialty surgical table and patient positioning markets. We are part of an international company, Mizuho Ikakogyo Co., Ltd. of Japan, who has more than 90 years of proven innovation in the medical device area, making us a truly global organization. We share a responsibility and commitment with our healthcare partn...

The Sr. Regulatory Affairs Specialist will independently plan, coordinate, conduct, and report on BD Biosciences Regulatory Affairs Programs. This includes activities such as preparation of clearance/approval/registration/licensure documentation for regulatory submissions to government agencies (U.S. and worldwide), performing tasks associated with obtaining and maintaining product clearances lice...