Sr. Regulatory Affairs Specialist JouléSr. Regulatory Affairs SpecialistMountain View, CA$55–$60 / hourSystem One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. Provide regulatory guidance to product teams, develop strategies for the U.S. and Canadian markets, and influence global regulatory strategies.
Regulatory Affairs Specialist IV JouléRegulatory Affairs Specialist IVMountain View, CA$60 / hourMinimum 8 years of regulatory affairs experience working in a medical device company (can be in combination with a regulatory affairs master degree; e.g., Masters in Regulatory Science). • Strong verbal and written communication skills, proven ability to translate technical documentation into effective internal documentation and regulatory submissions.
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.
NewRelationship Manager Senior CB City National BankRelationship Manager Senior CBLong Beach, CARemote$122,535–$208,715 / yearRelationships in portfolio may contain numerous accounts requiring extensive operational expertise to manage workflow to match client needs, risk control and maximize cross selling potential. This may be accomplished through active calling efforts and referrals from existing customers, providing the CNB exemplary level of service, identifying and promoting solutions to customer needs, and maintaining an active calling program.
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.
Regulatory Affairs Specialist II City of HopeRegulatory Affairs Specialist IIDuarte, CAIn preparation for these submissions, you will be responsible for interacting with internal personnel to include investigators and their staff (clinical research nurse and coordinator, biostatistician, and scientific leads), as well as Manufacturing, Quality Control, and Quality Assurance staff. Our dedicated and compassionate faculty and staff are driven by a common mission: Contribute to innovative approaches in predicting, preventing, and curing diseases, shaping the future of medicine through cutting-edge research.
Implant Direct Regulatory Affairs Specialist (Thousand Oaks, CA) EnvistaImplant Direct Regulatory Affairs Specialist (Thousand Oaks, CA)Los Angeles, CA$85,800–$104,800 / yearEnvista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. 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.
Implant Direct Regulatory Affairs Specialist (Thousand Oaks, CA) Envista Holdings CorpImplant Direct Regulatory Affairs Specialist (Thousand Oaks, CA)Thousand Oaks, CA$85,800–$104,800 / yearEnvista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. 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.
NewRegulatory Affairs Specialist Hologic IncRegulatory Affairs SpecialistSan Diego, CARegulatory Affairs Specialist manages assigned projects of moderate complexity which include international regulatory activities; on-market compliance reports or assessment of design changes, manufacturing process and labeling changes for regulatory reporting, as assigned. Participate in product development project teams which include new or existing products as the regulatory representative and provide guidance on global regulatory requirements for new/existing products.
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.
Senior Regulatory Affairs Specialist Iovance Biotherapeutics IncSenior Regulatory Affairs SpecialistSan Carlos, CARemote$140,000–$160,000 / yearWorks with submission authors and reviewers to ensure that source document planning is complete and that high-quality documents are approved on-schedule in terms of scientific content, organization, clarity, accuracy, format, consistency and adherence to regulatory guidelines, styles and processes. Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.
NewPrincipal Regulatory Affairs Specialist Shifamed LLCPrincipal Regulatory Affairs SpecialistLos Gatos, CA$150,000–$180,000 / yearSupira Medical, a clinical-stage Shifamed Portfolio Company, is developing a low-profile, high continuous flow percutaneous ventricular assist device (pVAD) to provide temporary mechanical circulatory support in high risk percutaneous coronary interventional (HRPCI) procedures as well as patients suffering from cardiogenic shock. Acts as company representative, developing and maintaining positive relationships with medical device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow‑up of submissions under review.
Regulatory Affairs Specialist- Remote Integrated Resources, IncRegulatory Affairs Specialist- RemoteNorthridge, CARemoteDirect or performs coordination and preparation of document packages for regulatory submissions related to the client separation from all areas of company, internal audits and inspections. Bachelor's degree in Life Sciences, Engineering, Chemistry, or related technical field 2-5 years of medical device regulatory experience.
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.
Associate Labeling Specialist - Regulatory Affairs Applied Medical Resources CorpAssociate Labeling Specialist - Regulatory AffairsRancho Santa Margarita, CA$71,000–$80,000 / yearThe Associate Labeling Specialist works cross-functionally to support labeling projects from design input through final approval, making this an ideal opportunity for professionals with a background in regulatory affairs, quality assurance, or technical writing in the medical device industry. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions.
NewPrincipal Regulatory Affairs Specialist ShifamedPrincipal Regulatory Affairs SpecialistLos Gatos, CaliforniaSupira Medical, a clinical-stage Shifamed Portfolio Company, is developing a low-profile, high continuous flow percutaneous ventricular assist device (pVAD) to provide temporary mechanical circulatory support in high risk percutaneous coronary interventional (HRPCI) procedures as well as patients suffering from cardiogenic shock. Acts as company representative, developing and maintaining positive relationships with medical device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow‑up of submissions under review.
Sr. Regulatory Affairs Specialist, Medical Devices (Long Beach, CA) BeautyHealthSr. Regulatory Affairs Specialist, Medical Devices (Long Beach, CA)Long Beach, CA$107,500–$125,000 / yearAn employee's pay position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, seniority, geographic location, performance, travel requirements, revenue-based metrics, any contractual agreements, and business or organizational needs. This includes developing regulatory planning, preparing submissions, ensuring ongoing compliance with applicable regulations such as U.S. FDA and international market regulations, and supporting cross-functional teams to bring innovative solutions to market safely and efficiently.
Senior Staff Regulatory Affairs Specialist Stryker CorpSenior Staff Regulatory Affairs SpecialistIrvine, CA$126,600–$210,900 / yearHowever, 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. As a Senior Staff Regulatory Affairs Specialist, you will influence global regulatory strategy across the full product lifecycle while partnering closely with product development, quality, and clinical teams.
Regulatory Affairs Specialist Quidelortho CorpRegulatory Affairs SpecialistSan Diego, CAQuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. Regulatory Operations provides infrastructure to the broader department through the creation and continuous improvement of regulatory processes, implementation and maintenance of regulatory software systems, and management of centralized regulatory services and support functions.