NewBenefits Specialist JobotBenefits SpecialistCerritos, CA$30–$40 / hourInformation collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. The successful candidate will be responsible for managing all aspects of our benefits programs, ensuring compliance with all relevant regulations, and providing exceptional service to our employees.
NewTreasury Specialist ProPivotalTreasury SpecialistNewport Beach, CAThis position is responsible for daily and monthly cash reconciliations, preparing journal entries, tracking receipts and disbursements, and resolving discrepancies. All ProPivotal job postings are either actual positions we had available at the time of posting and/or are representative of positions we typically fill or expect to fill.
NewGrievance and Appeals Nurse Specialist (LVN or RN) Kinetic Personnel GroupGrievance and Appeals Nurse Specialist (LVN or RN)Orange, CA$43–$65 / hourTemporaryUtilize computer and appropriate software (e.g., Microsoft Office: Excel, Outlook, PowerPoint, Word) and job-specific applications/systems to produce correspondence, charts, spreadsheets and/or other information applicable to the position assignment. A permanent position does include excellent CalPERS pension, 401a (4% contribution) and excellent government benefits and Holiday/PTO schedule.
Medical Claims Resolution Specialist Kinetic Personnel GroupMedical Claims Resolution SpecialistOrange, CA$25–$31 / hourTemporaryA full time permanent position includes a pay raise, telecommute options, a CalPERS Pension and excellent government benefits including generous holiday, PTO and sick pay days off, year one! Job duties: Addresses provider inquiries, questions, and concerns in all areas including enrollment, claims submission and payment, benefit interpretation, and referrals/authorizations for medical care.
NewGovernment Audit Recovery Specialist - 6 TalentBurst, Inc.Government Audit Recovery Specialist - 6Costa Mesa, CA$25 / hourAs an essential role and focal point of all government audit activity, the Government Recovery Specialist is responsible for responding to correspondence from Government Agencies related to Recovery Audit Contractor (RAC), Medicare Administrative Contractor (MAC), Targeted Provider Education (TPE), Comprehensive Error Rate Testing (CERT), Office of Inspector General (OIG), Quality Improvement Organizations (QIO) and other Medicaid, Medi-Cal regulatory auditing body for pre and post payment audits. Experience working on government, Recovery Audit Contractor (RAC), Medicare Administrative Contractor (MAC), Targeted Provider Education (TPE), Comprehensive Error Rate Testing (CERT), Office of Inspector General (OIG), and other Medicaid, Medi-Cal and other regulatory audits.
NewAssociate Clinical Research Specialist - Contract TalentBurst, Inc.Associate Clinical Research Specialist - ContractIrvine, CA$40–$45 / hourConducting reviews of documentation needed for internal and competent authority (e.g., FDA, DEKRA, PMDA) audits to ensure all essential Clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, the client’s internal SOPs, and US and OUS regulations. The main function of a clinical research specialist is to perform study start-up and conduct activities, including ICF review that meet regulatory requirements, creating study specific essential document lists, managing and communicating the status of study progress and activities.
NewIncident Response Specialist ECLAROIncident Response SpecialistFountain Valley, CAThis role involves managing and responding to security incidents, performing detailed investigations into breaches, and developing strategies to prevent future infractions. The ideal consultant is a critical thinker with a deep understanding of cyber threats and vulnerabilities, and a strong knowledge of IT systems and security infrastructure.
Compliance Specialist WSH Management, Inc.Compliance SpecialistIrvine, CA$38.46–$40.87 / hourConduct community audits, review internal screening determinations, complete and review AFHMPs, provide compliance guidance to site staff, and support agency audits, inspections, and corrective actions to maintain ongoing program compliance. Key Responsibilities • Audits Low Income Housing Tax Credit (LIHTC) and Housing and Urban Development (HUD) move-in and recertification files for all LIHTC and HUD-financed properties.
NewPetroleum Supply Specialist United States ArmyPetroleum Supply SpecialistBuena Park, ILRequirements: Attend a 21-week paid training program to gain skills and certifications in bulk fueling systems operations, fuel system maintenance, fuel accountability, forecasting, fuel distribution, bulk fuel distribution, petroleum storage, packaged petroleum logistics, petroleum shipment, environmental regulation compliance, hazmat compliance, emergency management, technical inspections, and OSHA regulations. Your position provides an opportunity for honing technical skills by acquiring expertise in assembling refueling systems and equipment, conducting precise quality assurance checks, and efficiently managing the supply and storage of fuel from a variety of sources.
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.
Regulatory Affairs Specialist, Sr. Glidewell DentalRegulatory Affairs Specialist, Sr.Irvine, CaliforniaBehind all of this success is an amazing group of people who are passionate about bringing innovation to the marketplace, while providing quality and affordability to better the lives of people all over the world. Demonstrated knowledge of Regulatory Affairs regulations, guidance, and procedures (Good Mfg Practice, Good Practices training programs, SOP development, and GMP audits and inspections).
Regulatory Affairs Specialist Sakura Finetek USARegulatory Affairs SpecialistTorrance, CaliforniaCollaborates with various internal departments, including Quality, Engineering, R&D, Customer Operations, Sales, and Marketing, as well as external stakeholders such as customers and suppliers, throughout pre-production, production, and post-production phases. Assisting in interactions with regulatory agencies, including submission review and on-site audit support (e.g., FDA inspections for future 510(k)s, IVDR audits related to CE marking design dossiers and technical documentation).
Sr. Regulatory Affairs Specialist, Medical Devices (Long Beach, CA) Beauty Health Group LimitedSr. 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.
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.
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 V eTeam Inc.Regulatory Affairs Specialist VLake Forest, CAThe role involves setting or executing regulatory strategy, leading and managing as a strategist, ensuring local product registration, facilitating health registration approvals, and supporting the Senior Director during due diligence and integration activities for Business Development & Licensing projects. A self-starter, assertive leader who will be accountable for the end-to-end regulatory support for the anterior/posterior ophthalmologic products, including new products, sustaining legacy products, and improvements to the product lines.
Associate Labeling Specialist – Regulatory Affairs Applied MedicalAssociate Labeling Specialist – Regulatory AffairsRancho Santa Margarita, California$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.
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.
Staff International Regulatory Affairs Specialist StrykerStaff International Regulatory Affairs SpecialistIrvine, 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. This is a meaningful opportunity to drive operational excellence, collaborate across global teams, and directly influence our ability to deliver safe, effective products to patients internationally.
Associate Specialist - Premarket Regulatory Affairs (Global) Applied Medical Resources CorpAssociate Specialist - Premarket Regulatory Affairs (Global)Rancho Santa Margarita, CA$70,000–$80,000 / yearOur unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute to a larger capacity than is possible in typical positions. Join Applied Medical as an Associate Specialist in Premarket Regulatory Affairs and help shape the future of medical innovation across our global markets.
Regulatory Affairs and Quality Assurance Specialist SprintRay IncRegulatory Affairs and Quality Assurance SpecialistHuntington Beach, CA$90,000–$120,000 / yearTo All Recruitment Agencies: Without a written agreement signed by an officer of SprintRay: a) SprintRay does not accept resumes from recruiting agencies, headhunters, or any other party expecting payment in the event SprintRay speaks with or hires a candidate from such submitted resume; b) SprintRay is not responsible for any fees related to unsolicited resumes or related Terms of Service, and c) Unsolicited resumes received will be considered the property of SprintRay and will be processed accordingly. Whether we're building next-generation AI tools, designing new materials, or supporting our customers on the front lines, we're united by the same passion-transforming digital dentistry and having fun while we do it.
Sr. Regulatory Affairs Specialist, Medical Devices (Long Beach, CA) BeautyHealthSr. Regulatory Affairs Specialist, Medical Devices (Long Beach, CA)Long Beach, CaliforniaAn 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.
Sr. Regulatory Affairs Specialist - Ad/Promo Prolacta BioscienceSr. Regulatory Affairs Specialist - Ad/PromoDuarte, CA$112,000–$125,000Experience coordinating cross-functional reviews, resolving comments, maintaining trackers, preparing status updates, and supporting timely completion of review, approval, submission, and record-retention activities. Review assigned advertising, promotional, labeling, packaging, digital, scientific, educational, technical, and other external-facing materials for regulatory compliance, intended use, claim support, accuracy, balance, and consistency with approved source documents.
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.
Senior Principal Regulatory Affairs Specialist Balt GroupSenior Principal Regulatory Affairs SpecialistIrvine, California$170,000–$200,000 / yearPrincipal Regulatory Affairs Specialist is a seasoned expert, responsible for completing and maintaining regulatory approvals/clearances for new and modified medical devices, license renewals, and annual registrations. Serves as a Regulatory representative on specific multi-discipline teams, responsible for organizing and leading meetings and acts independently to identify and resolve problems that may be complex in nature.
Associate Specialist, Regulatory Affairs Operations TMTT Edwards Lifesciences CorpAssociate Specialist, Regulatory Affairs Operations TMTTCalifornia, CA$59,000–$83,000 / yearWorking in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients' lives. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient's unmet clinical needs.
Clinical and Scientific - Regulatory Affairs Specialist V MindlanceClinical and Scientific - Regulatory Affairs Specialist VLake Forest, CA$80–$83 / 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. Expectations / Responsibilities: A self-starter, assertive leader who will be accountable for the End-to-End regulatory support for the anterior/posterior ophthalmologic products including, but not limited to, new products, sustaining legacy products, and improvements to the product lines.
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.
Junior Regulatory Affairs Specialist Pro-Dex IncJunior Regulatory Affairs SpecialistIrvine, CA$28.85–$31.25 / hourResponsibilities include support for QA/RA related operational activities within the Quality System that may include processes such as recall investigations/activities, Audits, Deviations and Process/Product Validations and Product Development/Design Control deliverables. Experience in industrial hygiene/safety, government regulations, EU MDR, ISO, MDSAP, operational auditing, work flow analysis, technical writing, and manufacturing operations preferred.
Regulatory Affairs Specialist (FDA, DEA ) BaRupOn LLCRegulatory Affairs Specialist (FDA, DEA )Irvine, CAThis position is responsible for preparing submissions, maintaining licenses, coordinating audits, and staying ahead of evolving federal and state regulations related to pharmaceuticals, medical devices, and controlled substances. The Regulatory Affairs Specialist (FDA, DEA) will ensure BaRupOn's pharmacy, manufacturing, and healthcare operations meet all applicable regulatory requirements.
Sr Regulatory Affairs Specialist Masimo CorpSr Regulatory Affairs SpecialistIrvine, CA$85,000–$110,000 / yearSr Regulatory Affairs Specialist is an accomplished regulatory professional with a successful work history with leading regulatory initiatives and partnering with Sales and Marketing teams in obtaining domestic and internal regulatory clearances for Masimo products to meet business objectives. The individual in this position will be capable of providing supported regulatory assessments of medical device regulations to help effective application of regulatory requirements to future products to ensure compliance of the product to pre-market regulatory clearances.
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.
NewRegulatory Affairs Specialist Scale MediaRegulatory Affairs SpecialistBurbank, CARemoteFull timePrepare and present industry updates at recurring team meetings (e.g., a monthly regulatory round-up), keeping cross-functional partners aware of what's happening and why it matters. Comfort with quality or product documentation basics — reviewing specifications or Certificates of Analysis (COAs) and meeting the documentation timelines that gate product release.
Jr. Regulatory Affairs Specialist- 100% onsite ConsultNetJr. Regulatory Affairs Specialist- 100% onsiteIrvine, CA$30–$31.25 / hourFor over 25 years, we have connected thousands of consultants with meaningful roles through a personal, communication-driven approach, partnering with a diverse client base to build high-performing teams and create lasting impact. Experience in industrial hygiene/safety, government regulations, EU MDR, ISO, MDSAP, operational auditing, work flow analysis, technical writing, and manufacturing operations preferred.
Regulatory Affairs and Quality Assurance Specialist SprintRayRegulatory Affairs and Quality Assurance SpecialistHuntington Beach, California$90,000–$120,000Without a written agreement signed by an officer of SprintRay: a) SprintRay does not accept resumes from recruiting agencies, headhunters, or any other party expecting payment in the event SprintRay speaks with or hires a candidate from such submitted resume; b) SprintRay is not responsible for any fees related to unsolicited resumes or related Terms of Service, and c) Unsolicited resumes received will be considered the property of SprintRay and will be processed accordingly. Whether we’re building next-generation AI tools, designing new materials, or supporting our customers on the front lines, we’re united by the same passion—transforming digital dentistry and having fun while we do it.
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.
Regulatory Affairs Specialist II Prolacta BioscienceRegulatory Affairs Specialist IIDuarte, CA$43–$49This position manages assigned deliverables, timelines, records, and documentation packages with focus on accuracy, completeness, traceability, and inspection readiness; identifies routine to moderately complex risks or gaps, supports mitigation activities, participates in assigned health authority interactions, provides practical regulatory support to stakeholders, and escalates complex or high-risk issues to management. A minimum of 3 years of Regulatory Affairs or relevant regulated industry experience, preferably in biologics, biopharmaceutical, pharmaceutical, infant formula, nutrition, medical product, or similarly regulated environment, with exposure to submissions, registrations, product dossiers, renewals, notifications, health authority correspondence, lifecycle management, controlled documentation, or regulatory operations.
NewRegulatory Affairs Specialist Actalent IncRegulatory 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. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.
Senior Specialist, Regulatory Affairs THV Edwards Lifesciences CorpSenior Specialist, Regulatory Affairs THVIrvine, CA$92,000–$130,000 / yearHow you will make an impact: Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving moderately complex conflicts between those requirements and development issues; also keeps management apprised of alternative actions. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients' lives.
Associate Specialist – Premarket Regulatory Affairs (Global) Applied MedicalAssociate Specialist – Premarket Regulatory Affairs (Global)Rancho Santa Margarita, California$70,000–$80,000 / yearOur unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute to a larger capacity than is possible in typical positions. Position Description: Join Applied Medical as an Associate Specialist in Premarket Regulatory Affairs and help shape the future of medical innovation across our global markets.
Senior Specialist, Regulatory Affairs Surgical Edwards LifesciencesSenior Specialist, Regulatory Affairs SurgicalIrvine, CA$92,000–$130,000 / yearPrepare, compile, and support global regulatory submissions for assigned products, including: U.S. submissions (e.g., 510(k)s, IDEs, PMAs, PMA supplements, annual reports) EU submissions under the Medical Device Regulation (MDR) (e.g., Technical Documentation, Design Dossiers, STEDs, clinical evaluation documentation, and responses to Notified Body questions) Support CE marking activities and interactions with Notified Bodies for Class III implantable devices. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients’ lives.
Clinical Research Regulatory Specialist University of Southern CaliforniaClinical Research Regulatory SpecialistLos Angeles, CA$75,968.95–$81,000 / yearWhen extending an offer of employment, the University of Southern California considers factors such as, but not limited to, the scope and responsibilities of the position, the candidate's work experience, education/training, key skills, internal peer equity, federal, state and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations. JOB ACCOUNTABILITIES: Learns and masters the creation, initiation, development, and revision of protocols, informed consents, case report forms, and other study and clinical research documentation to support principal investigators and quality assurance systems for the Clinical Investigations Support Office.
Regulatory Affairs Specialist, EHS, North America Henry Schein IncRegulatory Affairs Specialist, EHS, North AmericaCA$56,604–$88,443 / yearDevelop and deliver employee environmental, health, and safety (EHS) awareness and training programs to ensure compliance with applicable federal, state, and international regulations, including OSHA, OSHA State Plans (e.g., Cal/OSHA), DOT, IATA, IMO, and EPA requirements. Proficient in Microsoft Office applications, including PowerPoint, and experienced with project management methodologies and tools commonly used in the medical device or pharmaceutical industries.
Senior Regulatory Affairs Program Specialist Zoll Medical CorpSenior Regulatory Affairs Program SpecialistCARemote$105,000–$125,000 / yearThe Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Evaluate and resolve regulatory and technical issues due to extensive knowledge of medical device manufacturing and related regulatory requirements in this product sector through a clear understanding of the product development lifecycle.
Regulatory Specialist II, Clinical Trials Kaiser PermanenteRegulatory Specialist II, Clinical TrialsPasadena, CASupports research compliance by: learning to draft and submit clinical trial applications, under guidance, in compliance and consistency with all applicable federal, state, and local regulations and KP policies and procedures; assisting with the identification of compliance and/or quality issues, escalating as necessary; implementing updates to compliance-monitoring/audit systems and documentation with guidance; learning to and performing data entry tasks with minimal supervision to assist with risk-management; implementing research protocols, procedures, and guidance to ensure confidentiality, privacy, and security of clinical research data with minimal supervision; and leveraging basic research expertise to provide guidance to investigators and other key stakeholders to ensure compliance with IRB approved protocols and local and federal guidelines. Completes work assignments by applying up-to-date knowledge in subject area to meet deadlines; follows procedures and policies, and applies data and resources to support projects or initiatives with limited guidance and/or sponsorship.
Accreditation and Regulatory Specialist (Glendale) Adventist Health SystemAccreditation and Regulatory Specialist (Glendale)Glendale, CAReports to the Director or Manager of Accreditation & Regulatory Compliance and supports continuous regulatory readiness through audits, tracer activities, mock surveys, and gap analyses, while coordinating accreditation surveys and regulatory reviews. Maintains awareness of current and emerging regulatory requirements and prepare departments for surveys conducted by regulatory agencies and accrediting bodies (e.g., TJC, CMS, and State Departments of Health).
NewRegulatory & Compliance HC Specialist 4 - Risk Management FT Days University of California, IrvineRegulatory & Compliance HC Specialist 4 - Risk Management FT DaysOrange, CaliforniaFull timeAs Orange County’s only academic health systems, UCI Health is home to the only National Cancer Institute-designated comprehensive cancer center based in the county, the region’s only American College of Surgeons-verified Level I adult and Level II pediatric trauma center , American College of Emergency Physicians Gold Level 1 Geriatric Emergency Department and a nationally recognized regional burn center verified by the American Burn Association. *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.
Associate Director, Regulatory Affairs Global Regulatory Advertising and Promotion Arrowhead Pharmaceuticals IncAssociate Director, Regulatory Affairs Global Regulatory Advertising and PromotionPasadena, CA$180,000–$200,000 / yearProvide regulatory review and strategic guidance for promotional (branded and disease state) and medical communications for US prescription drug products across multiple channels, including digital, social media, websites, emails, print, speaker programs, video testimonials, scientific congresses, and field communications, among others. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
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.