NewManager, Accreditation & Regulatory Compliance (White Memorial) Adventist HealthManager, Accreditation & Regulatory Compliance (White Memorial)Torrance, 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.
NewPer Diem / PRN Outpatient Physical Therapist - $69 per hour Select MedicalPer Diem / PRN Outpatient Physical Therapist - $69 per hourLos Angeles, CASelect Medical is one of the largest operators of critical illness recovery hospitals (previously referred to as long term acute care hospitals), rehabilitation hospitals (previously referred to as inpatient rehabilitation facilities), outpatient rehabilitation clinics, and occupational health centers in the United States based on the number of facilities. Completes medical record documentation in a clear, concise, accurate and timely manner, inclusive of daily documentation, goal writing, FIM entry, letters of medical necessity, discharge documentation, and charge entry using approved formats in compliance with state, federal and intermediary guidelines and in accordance with the Hospital's policies and procedures.
Utility Regulatory Affairs Senior Advisor Edison InternationalUtility Regulatory Affairs Senior AdvisorRosemead, CAIn this job, you'll be developing and advocating the Company's positions associated with wholesale generation and energy storage interconnections to SCE's distribution system, including managing the development of revisions to SCE's wholesale distribution access tariff. Become a Utility Regulatory Affairs Senior Advisor at Southern California Edison (SCE) and help meet our goals of interconnecting clean energy resources to SCE's grid.
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.
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.
Associate Director, Regulatory Affairs (Global Regulatory Advertising and Promotion) Arrowhead PharmaceuticalsAssociate Director, Regulatory Affairs (Global Regulatory Advertising and Promotion)Los Angeles, 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.
NewRegulatory Affairs Specialist II 6029-MEDICAL DEVICE BUSINESS SERVICES Legal EntityRegulatory Affairs Specialist IIIrvine, CaliforniaUnder moderate supervision and in accordance with all applicable international, federal, state and local laws/regulations/requirements and Corporate Johnson & Johnson procedures and guidelines: Supports the preparation, compilation of regulatory submissions of technical and scientific medical device product information to US FDA, EU Notified Bodies, and other government regulatory agencies and assists in responding to regulatory authority queries and deficiency letters. Completes assignments for the creation and maintenance of regulatory documents and records related to FDA submissions, Technical Documentation, Design Dossiers, Letters to File, regulatory impact assessment of changes, and other regulatory documents for medical devices, including US Class II and III devices and EU MDR Class III devices.
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.
NewRegulatory 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.
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.
Senior Manager, Global Regulatory Affairs, CMC Jazz Pharmaceuticals PlcSenior Manager, Global Regulatory Affairs, CMCCARemote$140,000–$210,000 / yearThe successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. Participate and support as an active member of a multi-disciplinary team to establish Regulatory CMC strategies for commercial products, late- and early-stage development programs, under the supervision of GRA-CMC leadership.
NewRegulatory Affairs Specialist II Johnson & JohnsonRegulatory Affairs Specialist IIIrvine, CA$76,000–$121,900 / yearKey Responsibilities: Under moderate supervision and in accordance with all applicable international, federal, state and local laws/regulations/requirements and Corporate Johnson & Johnson procedures and guidelines: Supports the preparation, compilation of regulatory submissions of technical and scientific medical device product information to US FDA, EU Notified Bodies, and other government regulatory agencies and assists in responding to regulatory authority queries and deficiency letters. Completes assignments for the creation and maintenance of regulatory documents and records related to FDA submissions, Technical Documentation, Design Dossiers, Letters to File, regulatory impact assessment of changes, and other regulatory documents for medical devices, including US Class II and III devices and EU MDR Class III devices.
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).
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.
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.
Senior Manager, Regulatory Affairs TMTT Edwards LifesciencesSenior Manager, Regulatory Affairs TMTTIrvine, CA$145,000–$205,000 / 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. Includes representing the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including providing alternatives for meeting regulatory requirements and resolving complex conflicts between those requirements and development issues.
Senior Specialist Regulatory Affairs StrykerSenior Specialist Regulatory AffairsIrvine, California$95,800–$159,600 / 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. 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 Envista DentistryRegulatory Affairs SpecialistBrea, CaliforniaThis 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.
Sr. Program Lead, Regulatory Affairs 6010-Biosense Webster Legal EntitySr. Program Lead, Regulatory AffairsIrvine, CaliforniaAnalytical Reasoning, Business Writing, Coaching, Collaboration, Communication, Legal Support, Problem Solving, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Regulatory Reporting, Risk Assessments, Strategic Thinking . Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Sr. Program Lead, Regulatory Affairs Johnson & JohnsonSr. Program Lead, Regulatory AffairsIrvine, CaliforniaAnalytical Reasoning, Business Writing, Coaching, Collaboration, Communication, Legal Support, Problem Solving, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Regulatory Reporting, Risk Assessments, Strategic Thinking . Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.