NewManager, Accreditation & Regulatory Compliance (White Memorial) Adventist HealthManager, Accreditation & Regulatory Compliance (White Memorial)Culver City, CALeads site/network accreditation, regulatory compliance, and licensing operations, ensuring continuous readiness and alignment with Centers for Medicare & Medicaid Services (CMS), The Joint Commission, and state requirements. Job Summary: Directs day-to-day regulatory readiness activities, including internal audits, mock surveys, tracer programs, and regulatory education across clinical and operational departments at assigned hospitals/markets.
Regulatory Affairs Sr Manager, Regulatory Promotion & Material Compliance AmgenRegulatory Affairs Sr Manager, Regulatory Promotion & Material ComplianceThousand Oaks, CaliforniaIn addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients.
Regulatory Affairs Senior Director - Global Regulatory Leader - Oncology AmgenRegulatory Affairs Senior Director - Global Regulatory Leader - OncologyThousand Oaks, CaliforniaTo independently develop a comprehensive regulatory strategy for one or more high complexity programs, typically in late-stage development and/or with multiple indications, that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
Senior Regulatory Affairs Associate Aditi ConsultingSenior Regulatory Affairs AssociateNewbury Park, CARemote$29–$31 / hourConsent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. Qualifications: Master’s degree or Bachelor’s degree and 2 years of Regulatory Affairs experience or Associate’s degree and 6 years of Regulatory Affairs experience or High school diploma/GED and 8 years of Regulatory Affairs experience.
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.
Regulatory Affairs Senior Associate #26-18344 US Tech Solutions, Inc.Regulatory Affairs Senior Associate #26-18344Newbury Park, CARemote$32–$33.55 / hourUS Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. Description: In this vital role you will assist the US Regulatory Leads and the Global Regulatory Team (GRT) in the Regulatory Affairs organization.
Regulatory Affairs Senior Associate Aequor Technologies LLCRegulatory Affairs Senior AssociateNewbury Park, CAAs a member of the *** team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. *** is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions.
NewAssociate Director, Regulatory Affairs - Advertising/Promotion MannKind CorpAssociate Director, Regulatory Affairs - Advertising/PromotionWestlake Village, CAAdditional key job duties and responsibilities are as detailed below and will include: Providing strategic advice on advertising and promotional activities for assigned products in accordance with business goals and objectives, Maintaining current knowledge and understanding of FDA regulations/guidelines PhRMA guidelines and company policy and sharing new developments with impacted team members, Informs teams for assigned products and projects on implementation of compliant product labeling and communications. Job Summary: The Associate Director, Regulatory Affairs will be responsible for coordinating and completing regulatory review and approval of all commercial materials, representing the Regulatory team on both the Medical Review Committee (MRC) and Promotional Review Committee (PRC), and leading interactions with the FDA Office of Prescription Drug Promotion (OPDP) for respective products.
Senior Specialist, International (China) Regulatory Affairs Sonova Holding AGSenior Specialist, International (China) Regulatory AffairsValencia, CA$100,320–$125,400 / yearThis Valencia, CA-based role is responsible for helping obtain and maintain regulatory approvals, preparing local submissions, supporting in-country Regulatory Affairs representatives, assessing regulatory impact for product and process changes, and ensuring compliance with applicable pre-market and post-market requirements. Advanced Bionics is seeking a Senior Specialist, International Regulatory Affairs to support regulatory activities for Class III medical devices, with a primary focus on China and Taiwan market registrations.
Regulatory Affairs, Sr Manager – Obesity and Related Conditions AmgenRegulatory Affairs, Sr Manager – Obesity and Related ConditionsThousand Oaks, CaliforniaIn addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients.
Director of Regulatory Affairs Radiant Industries IncDirector of Regulatory AffairsEl Segundo, CACraft a modern regulatory strategy based in sound engineering principles with input from executives, our board of directors, and industry experts that brings the safest product to market the fastest. Portable nuclear power with rapid-deploy capability can replace similar-sized diesel generators and provide critical asset support for hospitals, data centers, remote sites, and military bases.
Senior Regulatory Affairs Manager - Digital Solutions (on-site) Abbott LaboratoriesSenior Regulatory Affairs Manager - Digital Solutions (on-site)Sylmar, CA$130,700–$261,300 / yearSupporting pre-market and post-market cross functional teams; developing and communicating global regulatory strategies for new product submissions or complex changes to on-market products. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.
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 Broadata CommunicationsRegulatory Affairs SpecialistTORRANCE, CA$120,000–$150,000 / yearThis role will support Class I and Class II medical device programs, including technical documentation, design history files, change control, risk management, supplier documentation, labeling review, customer regulatory requests, and audit readiness. Experience with Class II medical devices, 510(k) support, IEC 60601-1, EU MDR technical documentation, or customer-driven regulatory submissions is highly preferred.
Sr. Regulatory Affairs Specialist Caldera MedicalSr. Regulatory Affairs SpecialistWestlake Village, CA$100,000–$130,000 / yearPrepare, review, and submit and provide regulatory input and guidance to cross-functional partners regulatory documentation for medical device approvals in compliance with EU MDR, MDSAP, NMPA, TGA, ANVISA, ANMAT, and other relevant regulatory bodies and/or Distributors. From developing and authoring regulatory submissions to providing critical input on cross-functional project teams you will ensure submissions are accurately prepared and comply with global regulations.
Regulatory Affairs Specialist (Remote US) MindlanceRegulatory Affairs Specialist (Remote US)San Diego CA, CARemote$38–$40 / hourThis role will be responsible for preparing and coordinating regulatory documentation, maintaining regulatory records, and supporting global regulatory operations to ensure compliance with applicable regulations. We are seeking experienced Regulatory Affairs Specialists to support regulatory submissions and compliance activities for medical device products.
»Regulatory Affairs Allwin Medical Devices Inc»Regulatory AffairsCAEnsures compliance with ISO and Applicable regulatory requirements and Council of European Communities Regulations for medical devices. Coordinates & Conducting awareness of applicable regulatory and quality management requirement throughout the organization.
Global Regulatory Affairs Director - Inflammation and Rare Disease AmgenGlobal Regulatory Affairs Director - Inflammation and Rare DiseaseThousand Oaks, CaliforniaThe role of the Regulatory Affairs Director is to lead GRTs within Amgen’s GRAAS organization, develop a comprehensive regulatory strategy that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions, and to provide regulatory expertise and guidance to product teams. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
Director, Regulatory Affairs Strategy - Cell Therapy AstraZeneca PlcDirector, Regulatory Affairs Strategy - Cell TherapySanta Monica, CA$186,232–$279,349 / yearPartnering with senior leaders and global teams, you will lead strategy across key milestones-from expedited designations and Health Authority interactions through major submissions and post-approval maintenance-helping the business deliver transformative therapies at pace and with rigor. In this Director role, you will shape the regulatory path for programs that span oncology, immune-mediated and rare diseases-translating breakthrough science into timely approvals and competitive labeling that make a tangible difference to patients and markets.