Senior Director, Medical Affairs Waters CorporationSenior Director, Medical AffairsSan Diego, CAExperience in management of clinical and laboratory-based teams, leading teams remotely and managing projects effectively across geographical sites. • Develop and manage the Clinical Affairs team in support of clinical site selection, study design and execution of clinical trials and analytical validation studies to support regulatory and commercial goals.
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.
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.
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.
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.
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).
Senior Regulatory Affairs Specialist DexCom IncSenior Regulatory Affairs SpecialistSan Diego, CA$91,400–$152,300 / yearMeet the team: Join our world-class regulatory team and play a key role in bringing Dexcom's innovative products to markets worldwide. Dexcom's AAP may be viewed upon request by contacting Talent Acquisition at talentacquisition@dexcom.com.
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, 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 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.
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.
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.
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.
Implant Direct Regulatory Affairs Specialist (Thousand Oaks, CA) Envista DentistryImplant Direct Regulatory Affairs Specialist (Thousand Oaks, CA)Thousand Oaks, CaliforniaEnvista 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.
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.