NewRegulatory Affairs Consultant (Class III required) The Ranger GroupRegulatory Affairs Consultant (Class III required)Santa Clara, CAWe are seeking an experienced Regulatory Affairs Consultant for a large medical device customer to support sustaining activities for Class III medical devices. Support change control activities, including regulatory strategy, submission impact assessments, and regulatory documentation updates.
NewDirector Regulatory Affairs - CMC Clinical Dynamix, Inc.Director Regulatory Affairs - CMCSan Diego, CAResponsible for the regulatory CMC leadership of one or more commercial and development projects, including responsibility for regulatory strategy, IND/CTA preparation, maintenance and update activities, interaction with and preparation for key milestone meetings with regulatory agencies with focus on the CMC aspects. Extensive project regulatory leadership and expertise, specifically focused on the CMC aspects for small molecules, biologics, and/or gene therapies.
NewFinancial Specialists, All Other LL.US.13-2099 VoltFinancial Specialists, All Other LL.US.13-2099Santa Fe Springs, CA$35–$48 / hourWorked closely with Program Managers, Finance teams, Control Account Managers (CAMs), and Scheduling functions on the ASARS-2B Production Program, supporting Earned Value Management System (EVMS) reporting, analysis, and variance identification. Hybrid Pay Rate: $35.00 - $48.00 per hour Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.
NewPharmacy Program Specialist - Pharmacy Providence Health and ServicesPharmacy Program Specialist - PharmacySanta Monica, CA$29.62–$45.31 / hourSupport and assist in the coordination of Pharmacy Services activities including preparation of sterile compounds both hazardous and non-hazardous using aseptic technique, compounding pharmacy maintenance and scheduled cleanings, inventory management of drugs and infusion supplies, ordering, stocking and receiving of medications and supplies, processes specialty orders, and maintains and stocks automated dispensing machine (ADM) where applicable. Our not-for-profit network provides a full spectrum of care with leading-edge diagnostics and treatment, outpatient health centers, physician groups and clinics, numerous outreach programs, and hospice and home care, and even our own Providence High School.
Retail Operations Specialist Goodwill Southern CaliforniaRetail Operations SpecialistLos Angeles, CA$24–$26This role serves as the primary liaison between Goodwill Retail Services, external placement agencies, and retail leadership to ensure placements are effectively onboarded, monitored, and supported throughout their assignment. Through ongoing collaboration with site leaders and external partners, the Specialist promotes operational efficiency, consistency, and compliance across retail operations while ensuring that all placements are coordinated through approved and authorized agency partners.
Security Education & Training Specialist MANTECHSecurity Education & Training SpecialistEl Segundo, CAInterpret customer needs and through collaboration with subject matter experts and independent research, support the development of effective, high-quality training materials on matters pertaining to the full scope of the JAFAN and ICD series of publications. The primary function of the Security Education and Training Specialist is to implement a community-wide security education, awareness, and training program within the Air Force Special Access Program community.
NewService to the Armed Forces (SAF) Specialist, Mobile American National Red CrossService to the Armed Forces (SAF) Specialist, MobileFairfield, CA$64,900–$69,000Recruits and trains leadership volunteers to support placement and supervision of staff and programs in the delivery of SAF/IS U.S. programs and services, Training Services, Disaster Cycle Services, and providing support to Armed Forces Blood Services. Cultivates relationships and partnerships with external constituents in the local community, including government organizations, corporate partners, civic organizations, and other community charitable and nonprofit agencies with the purpose of furthering the mission of the Red Cross.
Specialist, WCD Programs Goodwill Southern CaliforniaSpecialist, WCD ProgramsLos Angeles, CAGoodwill SoCal is looking for a compassionate and organized WCD Programs Specialist to help participants overcome barriers and achieve employment success through personalized coaching and support. Goodwill is one of the leading non-profit brands in the world and one of the largest non-profits in Southern California.
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 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.
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.
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.
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.
Sr. Regulatory Affairs Specialist Caldera Medical IncSr. Regulatory Affairs SpecialistWestlake Village, CADuties and Responsibilities: Prepare, 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.
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.
Senior Specialist, International Regulatory Affairs Sonova Holding AGSenior Specialist, International Regulatory AffairsValencia, CA$100,320–$125,400 / yearAdvanced Bionics is seeking a Senior Specialist, International Regulatory Affairs to support global regulatory activities for Class III medical devices. Our team-customized hybrid work model empowers teams to balance individual needs with business goals, offering flexibility and individualized time management.
Principal Regulatory Affairs Specialist - APAC - Diabetes Care (on-site) Abbott LaboratoriesPrincipal Regulatory Affairs Specialist - APAC - Diabetes Care (on-site)Alameda, CA$100,000–$200,000 / yearCoordinate with cross functional teams including but not limited to: global Regulatory Affairs (e.g., APAC, CALA, EMEAP and US), Commercial, Marketing / PLC, Supply Planning, Customer Service, Quality, R&D, Operations, etc. to ensure all internal and external requirements are met prior to product release. This Principal Regulatory Affairs Specialist position is responsible for leading strategic planning as well as developing and deploying innovative solutions to ensure timely regulatory registration and release of products for distribution into specific geographies in the growing Asia Pacific (APAC) market.
NewSenior 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.
Principal Regulatory Affairs Specialist Procept Biorobotics CorpPrincipal Regulatory Affairs SpecialistSan Jose, CA$220,670–$259,610 / yearIt continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens. What Your Day-To-Day Will Involve: Regulatory representation and leadership to cross-functional products teams, development of regulatory strategies and support PROCEPT's products, marketing applications and post-market activities.
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.
Regulatory Affairs Specialist 4 ICONMA, LLCRegulatory Affairs Specialist 4Sunnyvale, CA$53.65–$58.65 / hourRequirements: Minimum 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). Regulatory working knowledge of product lifecycle management, design controls, risk management, verification and validation, and product labeling requirement.
Regulatory Affairs Specialist 4 eTeam Inc.Regulatory Affairs Specialist 4Sunnyvale, CA$58–$59 / hourStrong verbal and written communication skills, proven ability to translate technical documentation into effective internal documentation, and regulatory submissions. " Provide regulatory guidance to product teams, develop regulatory plans, and review and approve product design control documentation.
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 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.
Staff Regulatory Affairs Specialist Procept Biorobotics CorpStaff Regulatory Affairs SpecialistCAWhat Your Day-To-Day Will Involve: Act as a lead regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements. It continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens.
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.
Senior Regulatory Affairs Specialist Procept Biorobotics CorpSenior Regulatory Affairs SpecialistSan Jose, CA$148,550–$174,770 / yearIt continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens. Act as a lead regulatory representative on product development teams, communicate regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements.
Regulatory Affairs Specialist III Thermo Fisher Scientific IncRegulatory Affairs Specialist IIIFremont, CA$90,900–$121,200 / yearWe provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy.
Regulatory Affairs Specialist II Thermo Fisher Scientific IncRegulatory Affairs Specialist IIFremont, CA$72,000–$96,000 / yearWe provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy.
Senior Regulatory Affairs Specialist Intuitive Surgical IncSenior Regulatory Affairs SpecialistSunnyvale, CACertain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process). U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.
Regulatory Specialist Science CorpRegulatory SpecialistAlameda, CA$140,000–$185,000 / yearThis role will drive global regulatory strategies for our medical device and biologic products, guide cross-functional teams through complex regulatory pathways, and ensure our innovative technology reaches patients safely and efficiently. Spearhead rapid response efforts to regulatory agency communications, including deficiency letters, requests for additional information, and pre-submission feedback; drafting clear, persuasive responses while managing tight turnaround time.
Senior Regulatory Specialist Abbott LaboratoriesSenior Regulatory SpecialistPleasanton, CA$90,000–$180,000 / yearAn excellent retirement savings plan with high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists Our mission is to help people with heart failure survive and thrive. • Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements • Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Senior Regulatory Specialist AbbottSenior Regulatory SpecialistPleasanton, CaliforniaAt Abbott’s Heart Failure (HF) business, we pioneer and increase access to lifesaving, connected innovations that empower people to take control of their health by delivering seamless clinical solutions from diagnosis to monitoring and treatment. • As the Experienced professional in the Regulatory Affairs Sub-Function, possesses well developed skills in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
Regulatory Affairs Specialist 4 IconmaRegulatory Affairs Specialist 4Sunnyvale, CA$53.65–$58.65 / hourRequirements:Minimum 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). Regulatory working knowledge of product lifecycle management, design controls, risk management, verification and validation, and product labeling requirement.
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.
Principal Regulatory Affairs Specialist – Vascular (on-site) AbbottPrincipal Regulatory Affairs Specialist – Vascular (on-site)Temecula, South CarolinaThe Principal Regulatory Affairs Specialist will manage complex regulatory activities, including on-market product support, product development projects, lifecycle management initiatives, regulatory assessments, and global submissions. The candidate will have demonstrated experience preparing and executing regulatory strategies, supporting interactions with regulatory authorities and notified bodies, and successfully obtaining regulatory approvals for medical devices in the U.S., E.U. and other international markets.
Principal Regulatory Affairs Specialist – APAC - Diabetes Care (on-site) AbbottPrincipal Regulatory Affairs Specialist – APAC - Diabetes Care (on-site)Alameda, CaliforniaCoordinate with cross functional teams including but not limited to: global Regulatory Affairs (e.g., APAC, CALA, EMEAP and US), Commercial, Marketing / PLC, Supply Planning, Customer Service, Quality, R&D, Operations, etc. to ensure all internal and external requirements are met prior to product release. This Principal Regulatory Affairs Specialist position is responsible for leading strategic planning as well as developing and deploying innovative solutions to ensure timely regulatory registration and release of products for distribution into specific geographies in the growing Asia Pacific (APAC) market.
Principal Regulatory Affairs Specialist - Vascular (on-site) Abbott LaboratoriesPrincipal Regulatory Affairs Specialist - Vascular (on-site)Santa Clara, CA$100,000–$200,000 / yearThe Principal Regulatory Affairs Specialist will manage complex regulatory activities, including on-market product support, product development projects, lifecycle management initiatives, regulatory assessments, and global submissions. The candidate will have demonstrated experience preparing and executing regulatory strategies, supporting interactions with regulatory authorities and notified bodies, and successfully obtaining regulatory approvals for medical devices in the U.S., E.U. and other international markets.
Regulatory Affairs Specialist Actalent IncRegulatory Affairs SpecialistDavis, CA$38–$55 / hourIf you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options. Advise project teams on premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
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.
Senior Regulatory Affairs Specialist - Lingo (on-site) Abbott LaboratoriesSenior Regulatory Affairs Specialist - Lingo (on-site)Alameda, CA$90,000–$180,000 / yearIn this role, you will provide regulatory input on design and development activities to cross-functional teams, including software development and systems engineering members, and ensure availability of documentation to support submission activities to meet program objectives and timelines. Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for Class II software medical devices.
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.
Sr. Specialist, Regulatory Affairs MetagenicsSr. Specialist, Regulatory AffairsAliso Viejo, CaliforniaMonitors 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.
Regulatory Affairs Specialist Broadata CommunicationsRegulatory Affairs SpecialistTORRANCE, CAFull timeThis 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 I PhilipsRegulatory Affairs Specialist ISan Diego, CA$71,000–$112,000 / yearYou're the right fit if: You've acquired a minimum of 1+ years' experience in Regulatory Affairs within FDA regulated Medical Device environments with experience/exposure to 510(k)s, PMA supplements, EU MDR Technical Documents, and pre-submissions. The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.
Senior Regulatory Affairs Specialist - Manager Synaptic Medical LLCSenior Regulatory Affairs Specialist - ManagerCarlsbad, CAKey responsibilities: Lead the regulatory strategy for new product development and market entry, including 510(k), PMA, and CE Mark submissions. What we are looking for: Bachelor's degree in a scientific, engineering, or related field (RAC certification or advanced degree a plus).