We have other current jobs related to this field that you can find below

  • Regulatory Affairs Specialist

    3 months ago

    Santa Clara, United States GForce Life Sciences Full time

    Regulatory Affairs Specialist– Santa Clara, CA Must be able to work on a W2 Job Summary: We are seeking a regulatory affairs specialist to assist and lead in the definition/implementation of regulatory strategy and priorities in conjunction with management, peers, and commercial, and affiliate personnel in the medical device industry.Key...

  • Regulatory Affairs Specialist

    3 months ago

    Santa Clara, United States GForce Life Sciences Full time

    Regulatory Affairs Specialist– Santa Clara, CA Must be able to work on a W2 Job Summary: We are seeking a regulatory affairs specialist to assist and lead in the definition/implementation of regulatory strategy and priorities in conjunction with management, peers, and commercial, and affiliate personnel in the medical device industry.Key...

  • Lead Quality and Regulatory Affairs Specialist

    3 days ago

    Santa Clara, California, United States Intellectt Inc Full time

    Position: Senior Quality/Regulatory Affairs SpecialistCompany: Intellectt IncRole Overview:As a Senior Quality/Regulatory Affairs Specialist, you will play a pivotal role in ensuring compliance and quality within the regulatory affairs sector. Your expertise will be essential in supporting the regulatory affairs team from a quality assurance and compliance...

  • Regulatory Affairs Senior Specialist

    3 days ago

    Santa Clara, California, United States Abbott Full time

    About Abbott:Abbott is a prominent global healthcare organization dedicated to enhancing the quality of life for individuals at every stage of their journey. Our extensive range of transformative technologies encompasses various healthcare sectors, including diagnostics, medical devices, nutritionals, and branded generic medications. With a workforce of...

  • Lead Specialist in Regulatory Affairs

    3 days ago

    Santa Clara, California, United States Abbott Full time

    Lead Specialist in Regulatory AffairsAbbott stands as a prominent figure in the global healthcare sector, dedicated to enhancing the quality of life for individuals at every stage. Our extensive range of transformative technologies encompasses various healthcare domains, featuring top-tier businesses and products in diagnostics, medical devices,...

  • Regulatory Affairs Specialist

    4 weeks ago

    Santa Clara, United States Abbott Laboratories Full time

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.About...

  • Senior Regulatory Affairs Specialist

    3 months ago

    Santa Clara, United States Abbott Laboratories Full time

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.Working at...

  • Regulatory Compliance Specialist

    2 days ago

    Santa Clara, California, United States GForce Life Sciences Full time

    Regulatory Affairs SpecialistCompany: GForce Life SciencesEmployment Type: Full-time, 12-month contractOverview: GForce Life Sciences is seeking a dedicated regulatory affairs specialist. This role involves crafting and executing regulatory strategies in partnership with diverse stakeholders within the medical device sector.Primary Responsibilities:Develop...

  • Head of CMC Regulatory Affairs

    3 days ago

    Santa Clara, California, United States Bayside Solutions Full time

    Chief, CMC Regulatory Affairs - Strategic Leadership Opportunity at Bayside Solutions, Inc.Position Type: Full-Time with Direct HireCompensation: Competitive salary offeredLocation: Hybrid Work Environment in Redwood City, CAPosition Overview:In the role of Chief of CMC Regulatory Affairs, you will be instrumental in formulating and executing regulatory...

  • Senior Regulatory Affairs Consultant

    2 days ago

    Santa Clara, California, United States Direct Staffing Inc Full time

    Position Overview:We are seeking a highly skilled regulatory professional to join our Companion Diagnostics (CDx) team. The successful candidate will report to the Sr. Director of Regulatory Affairs (CDx) and must possess extensive global regulatory experience in In Vitro Diagnostics (IVD), Medical Devices, or Pharmaceuticals, with a proven track record of...

  • Principal Regulatory Affairs Specialist

    7 days ago

    Santa Clarita, United States huMannity Medtec Full time

    At HuMannity Medtec, we pioneer life-enhancing medical technologies for under met healthcare needs. Come join our team of engineers, scientists and medical device experts who are inspired to develop innovative solutions for tomorrow’s challenges. If you’d like to join a high-reward, truly inspiring environment with an experienced, diverse team working at...

  • Principal Regulatory Affairs Specialist

    1 week ago

    Santa Clarita, United States huMannity Medtec Full time

    At HuMannity Medtec, we pioneer life-enhancing medical technologies for under met healthcare needs. Come join our team of engineers, scientists and medical device experts who are inspired to develop innovative solutions for tomorrow’s challenges. If you’d like to join a high-reward, truly inspiring environment with an experienced, diverse team working at...

  • Senior Regulatory Affairs Consultant

    2 days ago

    Santa Clara, California, United States Direct Staffing Inc Full time

    Position Overview:We are seeking a highly skilled regulatory professional to join our Companion Diagnostics (CDx) team. The successful candidate will report directly to the Sr. Director of Regulatory Affairs (CDx) and must possess extensive global regulatory experience in In Vitro Diagnostics (IVD), Medical Devices, or Pharmaceuticals. A proven track record...

  • Regulatory Affairs Project Manager

    3 days ago

    Santa Clara, California, United States Intellectt Inc Full time

    Position: Regulatory Affairs Project ManagerCompany: Intellectt IncLocation: Santa Clara, CAJob Overview:Education: A Bachelor's degree is mandatory; a Master's degree is advantageous.Experience: At least 3 years of relevant experience is essential.Skills: Familiarity with US and/or Canadian regulations concerning product and/or device approval (FDA) is...

  • Regulatory Affairs, CMC Consultant

    3 weeks ago

    Santa Clara, United States Bayside Solutions Full time

    Regulatory Affairs, CMC ConsultantW2 ContractLocation: Redwood City, CA - Hybrid or Remote PSTJob Summary:In this role, you will be responsible for providing CMC regulatory strategies and leading the preparation of CMC sections of regulatory submissions to support the clinical development and eventual marketing approval of our pipeline compounds and...

  • Regulatory Affairs, CMC Consultant

    2 weeks ago

    Santa Clara, United States Bayside Solutions Full time

    Regulatory Affairs, CMC ConsultantW2 ContractLocation: Redwood City, CA - Hybrid or Remote PSTJob Summary:In this role, you will be responsible for providing CMC regulatory strategies and leading the preparation of CMC sections of regulatory submissions to support the clinical development and eventual marketing approval of our pipeline compounds and...

  • Regulatory Affairs, CMC Consultant

    2 weeks ago

    Santa Clara, United States Bayside Solutions Full time

    Regulatory Affairs, CMC ConsultantW2 ContractLocation: Redwood City, CA - Hybrid or Remote PSTJob Summary:In this role, you will be responsible for providing CMC regulatory strategies and leading the preparation of CMC sections of regulatory submissions to support the clinical development and eventual marketing approval of our pipeline compounds and...

  • Regulatory Affairs, CMC Consultant

    2 weeks ago

    Santa Clara, United States Bayside Solutions Full time

    Regulatory Affairs, CMC ConsultantW2 ContractLocation: Redwood City, CA - Hybrid or Remote PSTJob Summary:In this role, you will be responsible for providing CMC regulatory strategies and leading the preparation of CMC sections of regulatory submissions to support the clinical development and eventual marketing approval of our pipeline compounds and...

  • Regulatory Affairs Specialist II – Structural Heart

    2 months ago

    Santa Clara, United States Abbott Laboratories Full time

    About AbbottAbbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life....

  • Regulatory Affairs Project Leader

    3 months ago

    Santa Clara, United States Collabera Full time

    Job DescriptionJob Description·         Education: Bachelor's degree required, Master’s degree preferred·         Experience: Minimum of 3 years of Regulatory Affairs experience·         Skills: Knowledge of US and/or Canadian regulations or with EU and other international medical device regulations relating to product and/or...

Regulatory Affair Specialist

2 months ago

Santa Clara, United States Hire Talent Full time

Position: Regulatory Affair Specialist Location: Santa Clara, CA Duration: 1+ year of contract Responsibilities: Registrations - will train to do this Upto 200 pages of documentation formatting Complete technical documents for different Countries and submit to government agencies as well as the US. Knowledge of US and/or Canadian regulations or with EU and other international medical device regulations relating to product and/or device submissions. Hands-on experience with 510k submission, or PMA/s or US Annual report or CE Technical Documentation preparation. Assists in definition/implementation of regulatory strategy and priorities in conjunction with management, peers, commercial, and affiliate personnel. Communicates issues to management through project management tracking and issue briefings. Position is highly visible to internal and external stakeholders. High level of effective verbal and written communication skills must be demonstrated, including ability to negotiate, influence, and manage conflict. Prior regulatory experience in the medical device, food, dietary supplement, or pharmaceutical industry is strongly preferred, but not required. Ability to work constructively, decisively, and collegially with internal customers (scientists, marketing, quality assurance, product development, affiliates) to solve problems and communicate regulatory needs. Ability to manage and track broad and strategic projects. Ability to communicate effectively in writing crisp briefings and issue analysis. Demonstrated ability to work effectively in a team environment. Responsible for tracking and timely completion of regulatory strategies and issues, scientific substantiation for product claims, and label material activities. Responsible for effective communication of regulatory requirements to project teams and internal customers. Qualification:

Bachelor's degree in engineering or science and a minimum of 3 years of experience in regulatory affairs. Required Skills: Must have RA submission experience and EU & US submissions experience Knowledge of US and/or Canadian, EU regulation relating to product and/or device clearance (FDA) Creation and/or maintenance of EU MDR Technical Documentation Prepare and submit product for international registration PMA, IDE submission 510(k) submission Good writing and communication skills - Word, Excel

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