Regulatory Affairs Specialist

1 week ago


Sunnyvale, California, United States IntelliPro Group Inc. Full time

pbJobTitle:/bRegulatoryAffairsSpecialist/ppbJobSummary:/b/ppWeareseekingahighlyskilledRegulatoryAffairsSpecialisttojoinourteamatIntelliProGroupInc.Theidealcandidatewillhaveastrongunderstandingofregulatoryframeworksandbeabletomanagesmallprojectswithexceptionalorganizationandindependence./ppbKeyResponsibilities:/b/pulliManage510(k)submissionsandparticipateinthepreparationandreviewofregulatorysubmissionstotheUSFDAandinternationalregulatoryauthorities./liliWorkcloselywithQuality,Engineering,ProductManagement,Marketing,andSalesteamstoperformregulatorypre-andpost-marketanalysis./liliImplementandmaintainanISO13485andFDAcompliantQualityManagementSystem./liliSupportgovernmentinteractionspertainingtomedicaldeviceregistrationsandlicensing./liliParticipateinthedevelopmentofregionalregulatorystrategyandupdatestrategybasedonregulatorychanges./li/ulpbRequirements:/b/pulliAminimumof5yearsofexperienceinmedicaldeviceRegulatoryAffairs./liliDemonstratedabilitytomanagesmallprojectsanddisplayexceptionalorganization,independence,andoutcome-drivenfocus./liliOutstandinganalyticalandcommunicationskills,pairedwithastrongsenseofteamworkandmeticulousattentiontodetail./li/ulpbAboutUs:/b/ppIntelliProGroupInc.isagloballeaderintalentacquisitionandHRsolutions.Wearecommittedtodeliveringunparalleledservicetoclients,fosteringemployeegrowth,andbuildingenduringpartnerships./ppbCompensation:/b/ppThepayofferedtoasuccessfulcandidatewillbedeterminedbyvariousfactors,includingeducation,workexperience,location,jobresponsibilities,certifications,andmore.Additionally,IntelliProprovidesacomprehensivebenefitspackage,allsubjecttoeligibility./p



  • Sunnyvale, California, United States Ihealth Labs Inc Full time

    Job Title: Sr. Regulatory Affairs SpecialistJoin iHealth Labs Inc, a leading provider of cloud-connected medical devices, personal health care devices, and home-based tests, as a Sr. Regulatory Affairs Specialist. In this role, you will be part of the regulatory team responsible for proper oversight of medical device development and market introduction.Key...


  • Sunnyvale, California, United States Ihealth Labs Inc Full time

    Job Title: Sr. Regulatory Affairs SpecialistJoin iHealth Labs Inc, a leading provider of cloud-connected medical devices, personal health care devices, and home-based tests, as a Sr. Regulatory Affairs Specialist. In this role, you will be part of the regulatory team responsible for proper oversight of medical device development and market introduction.Key...


  • Sunnyvale, California, United States Ihealth Labs Inc Full time

    Job OverviewiHealth Labs Inc is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring the compliance of our medical devices with FDA regulations and international standards.The ideal candidate will have a strong background in regulatory affairs, with a minimum of...


  • Sunnyvale, California, United States IntelliPro Group Inc. Full time

    Job OverviewIntelliPro Group Inc. is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory frameworks and guidelines for medical device development and market introduction.Key ResponsibilitiesDevelop and implement regulatory strategies to...


  • Sunnyvale, California, United States Intuitive Full time

    Job DescriptionAt Intuitive, we are united behind our mission to advance the world of minimally invasive care. We are seeking a highly skilled Director of Regulatory Affairs to join our team and lead the regulatory strategy for our imaging agent drug development program.Key ResponsibilitiesDevelop and implement the program's domestic regulatory strategy and...


  • Sunnyvale, California, United States Intuitive Full time

    Job Title: Patient Advocacy SpecialistAt Intuitive, we are committed to advancing the world of minimally invasive care. As a Patient Advocacy Specialist, you will play a critical role in protecting and promoting our company's mission.Job SummaryThis position will contribute to all facets of the Global Public Affairs team's mission, including developing and...


  • Sunnyvale, California, United States Intuitive Full time

    Job Title: Patient Advocacy SpecialistAt Intuitive, we are united behind our mission to advance minimally invasive care. As a Patient Advocacy Specialist, you will play a critical role in protecting and promoting our company's interests while advocating for patients and their families.Key Responsibilities:Develop and implement patient and policy advocacy...


  • Sunnyvale, California, United States Intuitive Full time

    Job DescriptionAs a member of the Global Public Affairs team at Intuitive Surgical, the Patient Advocacy Specialist plays a crucial role in advancing the company's mission to protect and promote patient interests.Key ResponsibilitiesDevelop and implement patient advocacy strategies and tactics to advance Intuitive's policy positions.Plan and facilitate...


  • Sunnyvale, California, United States Intuitive Full time

    Job Title: Patient Advocacy SpecialistAt Intuitive, we are united behind our mission to advance minimally invasive care. As a Patient Advocacy Specialist, you will play a critical role in protecting and promoting our company's interests while advocating for patients and their families.Key Responsibilities:Develop and implement patient advocacy strategies and...

  • EHS Specialist

    4 weeks ago


    Sunnyvale, California, United States Intuitive Full time

    Job Title: EHS SpecialistAt Intuitive, we are committed to creating a culture of safety and excellence. We are seeking an experienced EHS Specialist to join our team and contribute to our mission of advancing minimally invasive care.Job Summary:We are looking for a highly skilled EHS Specialist to work with our local process owners and business partners to...


  • Sunnyvale, California, United States Cepheid Full time

    About the RoleCepheid is seeking a visionary and passionate Vice President of Product Innovation Management to join our team in Sunnyvale, CA. As a critical leadership role, you will be responsible for defining and prioritizing Cepheid's innovation and R&D pipeline for future diagnostic solutions.Key ResponsibilitiesLead the development and execution of a...


  • Sunnyvale, California, United States Randstad Full time

    Credentialing SpecialistWe are seeking a skilled Credentialing Specialist to join our team at Randstad. As a Credentialing Specialist, you will play a critical role in ensuring the accuracy and completeness of medical staff credentialing files, ensuring compliance with regulatory standards and supporting Medical Staff Services operations.Key...


  • Sunnyvale, California, United States Randstad Full time

    Job SummaryWe are seeking a skilled Credentialing Specialist to join our team at Randstad. As a Credentialing Specialist, you will play a critical role in ensuring the credentialing and recredentialing processes for medical staff and allied health professionals are compliant with regulatory standards.Key ResponsibilitiesOversee the credentialing and...


  • Sunnyvale, California, United States Intuitive Full time

    Job Title: Quality Engineer 4At Intuitive, we are united behind our mission: to revolutionize minimally invasive care through innovative technology and design. We are seeking an exceptional Quality Engineer 4 to support the development of next-generation innovation products.Job Summary:The Quality Engineer 4 will play a critical role in ensuring that our...

  • Validation Specialist

    1 month ago


    Sunnyvale, California, United States GForce Life Sciences Full time

    Job SummaryWe are seeking a highly skilled Validation Specialist to join our team at GForce Life Sciences.The successful candidate will be responsible for developing and implementing validation plans, protocols, and reports to ensure compliance with FDA regulations and industry standards.Key ResponsibilitiesDevelop and approve validation plans, IQ, OQ...


  • Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionAt Intuitive Surgical, we are seeking a highly skilled Senior Validation Engineer to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the safety and efficacy of our medical devices through rigorous testing and validation of cleaning, disinfection, and sterilization processes.The ideal candidate...


  • Sunnyvale, California, United States Intuitive Full time

    Job DescriptionAt Intuitive, we are united behind our mission: to advance minimally invasive care through ingenuity and intelligent technology. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference.We believe great ideas can come from anywhere. We strive to foster an...


  • Sunnyvale, California, United States Intuitive Full time

    Job DescriptionAt Intuitive, we are committed to advancing the world of minimally invasive care. We are seeking an exceptional Quality Engineer to support the development of next generation innovation products.Primary Function of Position:Intuitive Surgical designs and manufactures highly complex surgical systems, including cameras, instruments, and...

  • Technical Writer

    2 weeks ago


    Sunnyvale, California, United States Kelly Science, Engineering, Technology & Telecom Full time

    Job Title: Technical WriterWe are seeking a skilled Technical Writer to join our team at Kelly Science & Clinical. As a Technical Writer, you will be responsible for creating high-quality documentation for our client's in vitro diagnostic tests and instrument systems.Key Responsibilities:Develop and publish user manuals, guides, and other documentation for...

  • Commissioning Agent

    2 weeks ago


    Sunnyvale, California, United States iParametrics LLC Full time

    Job Title: Commissioning Agent - Process Systems SpecialistiParametrics LLC is seeking a highly skilled Commissioning Agent to oversee the commissioning of high purity, bulk gas, and specialty chemical systems. This role requires expertise in process systems, commissioning procedures, and relevant safety and regulatory standards.Key Responsibilities:Oversee...