NewQuality Assurance Specialist JouléQuality Assurance SpecialistOntario, CASystem One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. Experience within Consumer Packaged Goods (CPG), Cosmetics, OTC, Medical Device, or related industries.
Vice President, Medical Affairs, Clinical Operations & Regulatory Affairs Dendreon CorporationVice President, Medical Affairs, Clinical Operations & Regulatory AffairsSeal Beach, CaliforniaThis executive role ensures alignment across scientific communications, product lifecycle management, clinical development, and regulatory strategy to support the successful development, approval, and commercialization of the company's products and contract manufacturing services (CMS) pipeline. Develop and maintain strategic relationships with physicians, investigators, Key Opinion Leaders (KOLs), healthcare providers, and scientific experts to support clinical development, evidence generation, product adoption, and medical education initiatives.
Principle Regulatory Affairs Strategy Associate Sunrise Systems IncPrinciple Regulatory Affairs Strategy AssociateLake Forest, CA$79.71–$83.33 / hourThe Principle Regulatory Affairs Strategy Associate, reporting to the Senior Director of Regulatory Affairs (LLSI), is primarily responsible for setting or executing the regulatory strategy, leading and managing, acting as a strategist, ensuring local product registration and facilitating health registration approvals, and supporting the Senior Director during due diligence and integration activities for Business Development & Licensing projects. Coordinate regulatory activities, including product submissions, renewals, and updates, by liaising with plants, agents, and governmental authorities to ensure timely submissions and approvalsOversee promotional material approval for Alcon ME/KSA portfolio, ensuring ethical conduct and compliance with national and international laws, codes, and regulations.
Regulatory Affairs Specialist EnvistaRegulatory Affairs SpecialistBrea, CA$85,800–$104,800 / yearThis individual is responsible for obtaining global regulatory registrations/approvals based on company objectives, attending product development meetings, regional alignment; as well as collaborating with cross-functional departments to ensure country-specific requirements are met and integrated throughout the design control and post-product launch activities. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening.
Regulatory Affairs Specialist II Envista Holdings CorpRegulatory Affairs Specialist IIBrea, CA$85,800–$104,800 / yearThis individual is responsible for obtaining global regulatory registrations/approvals based on company objectives, attending product development meetings, regional alignment; as well as collaborating with cross-functional departments to ensure country-specific requirements are met and integrated throughout the design control and post-product launch activities. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening.
Vice President, Quality & Regulatory Affairs Nihon Kohden America, LLCVice President, Quality & Regulatory AffairsIrvine, CA$215,000–$300,000 / yearThe Vice President serves as the primary liaison with regulatory authorities and certification bodies and partners closely with Nihon Kohden Corporation (NKC) to identify and implement the most efficient, compliant, and customer-focused approaches to regulatory, quality, and post-market activities. Serving as the Company's Management Representative, this position ensures the effectiveness and continuous improvement of the Quality Management System (QMS) while supporting the Company's sales, marketing, service, clinical support, and product lifecycle management activities.
Vice President, Quality & Regulatory Affairs Nihon Kohden CorpVice President, Quality & Regulatory AffairsIrvine, CAThe Vice President serves as the primary liaison with regulatory authorities and certification bodies and partners closely with Nihon Kohden Corporation (NKC) to identify and implement the most efficient, compliant, and customer-focused approaches to regulatory, quality, and post-market activities. Serving as the Company's Management Representative, this position ensures the effectiveness and continuous improvement of the Quality Management System (QMS) while supporting the Company's sales, marketing, service, clinical support, and product lifecycle management activities.
NewVice President, Quality Assurance & Regulatory Affairs Nihon Kohden Orange MedVice President, Quality Assurance & Regulatory AffairsSanta Ana, CA$190,000–$230,000 / yearProvide regulatory leadership for Class I and Class II medical devices, including product classification, regulatory pathways, pre-market submissions, registrations, clearances, approvals, and post-market requirements. Ensure the Quality Management System effectively supports the full product lifecycle, including design and development, manufacturing, supplier management, production, distribution, servicing, and post-market activities.
Regulatory Affairs Coord I MemorialCare Health SystemRegulatory Affairs Coord IFountain Valley, CA$32.19–$46.68 / hourFor investigator initiated studies, assist the Principal Investigator (PI) and study team with the preparation, organization, submission support, tracking, and maintenance of applicable Food and Drug Administration (FDA) documents and correspondence, in compliance with FDA regulations, local Institutional Review Board (IRB) policies, and institutional requirements. We are committed to increasing access to patient-centric, affordable, and high-quality healthcare; your personal contributions are integral to MemorialCare''s recognition as a market leader and innovator in value-based and other care models.
Regulatory Affairs Specialist Nihon Kohden Orange MedRegulatory Affairs SpecialistSanta Ana, CA$80,000–$95,000 / yearCoordinates regulatory requests from Sales Offices and internal stakeholders, including Certificates to Foreign Governments (CFGs), Certificates of Free Sale, authentications, and other regulatory certificates or documentation. Ensures regulatory information for assigned products and markets is current and supports timely retrieval and presentation of documentation for internal stakeholders, regulatory authorities, audits, inspections, and other authorized requests.
NewManager, Regulatory Affairs (Companion Diagnostics) Quest Diagnostics IncManager, Regulatory Affairs (Companion Diagnostics)San Juan Capistrano, CARemoteJob DescriptionThe Regulatory Affairs Manager will create, evaluate and execute domestic and/or international regulatory tasks related to the following: global submissions, technical file compilation, facility registrations, special projects and strategy to drive market growth worldwide. This is a Remote opportunity Pay Range: $120,000 - $150,000/ year, 10% Bonus (The final offer and compensation package for this role may vary depending on the candidate''s geographic location.)Salary offers are based on a wide range of factors including relevant skills, training, experience, education, and, where applicable, certifications obtained.
Sr. Specialist, Regulatory Affairs Metagenics LLCSr. Specialist, Regulatory AffairsAliso Viejo, CAIndustry Surveillance: Monitors competitive claims, FDA's and FTC''s actions, litigation, news releases and other sources, as they relate to the current science of Metagenics-related products and challenges to relevant product claims, to ensure that Metagenics limits its exposure for product claims both domestically and internationally. The wage range for this role takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; and other business and organizational needs.
Regulatory Affairs Coordinator University of California, IrvineRegulatory Affairs CoordinatorOrange, CaliforniaFull timeProven organizational skills and attention to detail; ability to multi-task, prioritize a complex and dynamic workload, meet rigid deadlines despite interruptions, frequent workload changes and competing demands, and achieve high productivity/quality within short time frames; skill in working independently, taking initiative and following through on assignments and ability to work as part of a team. *Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; received notice of any allegations or are currently the subject of any administrative or disciplinary proceedings involving misconduct; have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct; or have filed an appeal of a finding of misconduct with a previous employer.
Regulatory Affairs Specialist Envista DentistryRegulatory Affairs SpecialistBrea, California$85,800–$104,800 / yearThis individual is responsible for obtaining global regulatory registrations/approvals based on company objectives, attending product development meetings, regional alignment; as well as collaborating with cross-functional departments to ensure country-specific requirements are met and integrated throughout the design control and post-product launch activities. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening.
NewVice President, Quality Assurance & Regulatory Affairs Nihon Kohden OrangeMed IncVice President, Quality Assurance & Regulatory AffairsSanta Ana, CA$190,000–$230,000 / yearProvide regulatory leadership for Class I and Class II medical devices, including product classification, regulatory pathways, pre-market submissions, registrations, clearances, approvals, and post-market requirements. The VP, QA/RA is accountable for maintaining a robust and effective quality management system, ensuring regulatory compliance across the Companys product portfolio and markets, and establishing quality and regulatory strategies that support the Companys business objectives and continued growth.
Senior Specialist Regulatory Affairs StrykerSenior Specialist Regulatory AffairsIrvine, CaliforniaHowever, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. In this role, you will support regulatory strategy, submissions, and product lifecycle activities across a range of projects, partnering with cross-functional teams to navigate regulatory requirements and maintain product compliance in global markets.
Regulatory Affairs Specialist Nihon Kohden OrangeMed IncRegulatory Affairs SpecialistSanta Ana, CA$80,000–$95,000 / yearCoordinates regulatory requests from Sales Offices and internal stakeholders, including Certificates to Foreign Governments (CFGs), Certificates of Free Sale, authentications, and other regulatory certificates or documentation. Ensures regulatory information for assigned products and markets is current and supports timely retrieval and presentation of documentation for internal stakeholders, regulatory authorities, audits, inspections, and other authorized requests.
Regulatory Affairs Manager Huisong PharmaceuticalsRegulatory Affairs ManagerSanta Ana, California$38–$48Position Overview Huisong Inc. is seeking an experienced Regulatory Affairs Manager to support regulatory strategy and compliance for dietary supplements, botanical ingredients, herbal extracts, and Traditional Chinese Medicine products. Founded in 1998, Huisong Pharmaceuticals specializes in the research, development, and manufacturing of premium-quality natural ingredients for leading companies in the pharmaceutical, nutraceutical, food and beverage, and personal care industries.
Regulatory Affairs and Compliance Senior Advisor Edison InternationalRegulatory Affairs and Compliance Senior AdvisorRosemead, CA$161,700–$242,600 / yearIn this job, you'll act as the External Regulatory Audit Manager, responsible for managing the Company's response to multiple external regulatory audits simultaneously conducted by the CPUC, Office of Electric Infrastructure Safety (OEIS), FERC, 3rd Party Auditors, NERC and WECC that have financial, operational, and/or regulatory impact on the Company. Experience working in any of the following organizational units: Energy Procurement, Transmission and Distribution, Customer Service Programs, Regulatory Affairs, or Finance.
Regulatory Affairs Specialist - Vascular (on-site) AbbottRegulatory Affairs Specialist - Vascular (on-site)Temecula, South CarolinaOur extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. The ideal candidate will possess strong analytical and project management skills, a working knowledge of medical device regulations, and the ability to interpret complex regulatory requirements and apply them to product development and lifecycle management activities.