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About the RoleThe Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products, with a focus...  ...skills, assertiveness, excellent negotiation and project management skills evidenced by past performance on drug development project... 
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Tarsus Pharmaceuticals

Irvine, CA
1 day ago
 ...cGMP requirements, ISO standards, ICH guidelines, and quality management systems. You should have excellent communication, grammar,...  ...based in Santa Ana/Costa Mesa, California. The role of a Regulatory Affairs Manager is crucial in ensuring that our products comply with... 
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Synectics Inc

Santa Ana, CA
9 days ago
 ...personal touch. For more information, visit Follow Allergan Aesthetics on LinkedIn. Job Description Description The Manager Regulatory Affairs represents US regulatory affairs for device development projects. Executes US regulatory strategic plans and provides... 
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AbbVie

Irvine, CA
4 days ago
 ...Lifesciences, please consult this 2023 Investor Conference Presentation, pages 89-99. How you will make an impact: As a Manager, Regulatory Affairs, you are responsible for completing and maintaining regulatory approvals and clearances of assigned products.... 
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Edwards Lifesciences Corporation

Irvine, CA
5 days ago
 ...Job Description: The Regulatory Affairs Specialist will be responsible for establishing, coordinating, and executing user experience...  ...communications in support of Ormco Product Development. This position manages the design, study preparation, conducts, and close-out of... 
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Envista

Brea, CA
2 days ago
Job details Regulatory Affairs Specialist The Regulatory Affairs Specialist II, will provide administrative and technical support to...  ...Specialist provides direct Worldwide Regulatory support to lifecycle management and new product development/new product introduction... 
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Worldwide

Kelly Services

Irvine, CA
1 day ago
 ...Description We're looking for a Regulatory Affairs Associate , working in Biotechnology/Medical Devices industry in 100 Abbott Park Road, Lake Forest, Illinois, 60064, United States . Job description: Responsible for filing necessary applications and... 
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PSG Global Solutions

Lake Forest, CA
5 days ago
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 ...Reporting directly to the CEO, the Senior Regulatory Specialist is responsible to plan,...  ...Product Regulatory and Regional Regulatory Affairs colleagues to drive timely and accurate...  ...Duties and Responsibilities include... Manages and coordinates international product registration... 
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Neurovasc Technologies Inc.

Irvine, CA
5 days ago
Overview: Represents the Regulatory Affairs function in project teams, and manages regulatory projects to established timelines and budgets. Oversees and ensures compliance with state, federal and International medical device regulations and overall regulatory departmental... 
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Endologix

Irvine, CA
3 days ago
 ...medical device company, has an immediate opening for a Senior Regulatory Affairs Specialist responsible for implementing regulatory...  ...relationship skills including negotiating and relationship management ~ Ability to apply sound judgment when making decisions and... 
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OrthAlign Inc.

Irvine, CA
7 days ago
Position SummaryThe primary responsibility of the Senior Regulatory Affairs Specialist is to manage and perform regulatory submissions for local and worldwide regulatory agencies. The Sr. RAS is also responsible for ensuring products and procedures comply with regulatory... 
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Biotalent Ltd

Laguna Woods, CA
5 days ago
 ...The Regulatory Affairs Specialist temp is responsible for developing and influencing regulatory policy and determining and pursuing courses...  ...compliance experience ~ Experience with product lifecycle management, premarket and post-market product line support. ~ Strong... 
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Nihon Kohden America

Irvine, CA
3 days ago
 ...for Clinical Research Operations Working Title: Assistant Regulatory Affairs Coordinator Department: UCI Ctr for Clinical Research...  ...with the Lead Regulatory Coordinator to ensure successful management of the regulatory aspects of each study conducted through UCI... 
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University of California - Irvine Health

Orange, CA
5 days ago
 ...AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Manager, Regulatory Affairs In Vitro Diagnostics and Companion Diagnostics works with internal and external partners to develop and implement global... 
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AbbVie

Irvine, CA
2 days ago
 ...Description Job Description Summary: The main function of a regulatory affairs specialist is to complete and maintain regulatory approvals...  ...requirements and development issues, and/or reporting to management. Participate in providing guidance and feedback to... 
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Trinus

Irvine, CA
7 days ago
 ...Job Description Job Description Job Posting Summary: Seeking a Regulatory Affairs Specialist to manage updates and compliance for technical files and labeling under the new IVDR requirements, ensuring seamless transition from IVD Directive. Job Requirements:... 
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Entegee

Irvine, CA
27 days ago
 ...Description   The Associate Director of Regulatory Innovation supports regulatory...  ...Aesthetics products including coordination, management of global submissions. Directs and supports...  ...Safety and International Regulatory Affairs colleagues. ~ Provides regulatory policy... 
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Allergan Aesthetics

Irvine, CA
21 days ago
Job TitlePrincipal Regulatory Affairs SpecialistJob DescriptionPrincipal Regulatory Affairs Specialist (U.S. Hub based)Clinical Integration...  ...opportunity to work closely with Clinical Affairs, Product Management and R&D to ensure its success.Your role:* Ensure that products... 
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Philips

Orange, CA
5 days ago
 ...primary responsibility of the position is to support regulatory strategy and registration across global markets...  ...customers. Responsibilities: The Regulatory Affairs Specialist (RAS) is responsible for the management of global and regional regulatory projects,... 
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Cordis

Irvine, CA
5 days ago
 ...Depending on experience Summary: The main function of a regulatory affairs specialist is to complete and maintain regulatory approvals...  ...those requirements and development issues, and/or reporting to management. Participate in providing guidance and feedback to... 
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Planet Group

Irvine, CA
1 day ago