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

  • 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 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 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...

  • 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...

  • 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...

  • 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...

  • 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...

  • 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...

  • Senior Regulatory Affairs Specialist

    1 week ago

    Santa Clarita, United States BioTalent Full time

    *Hybrid on-site role in Valencia, CA - at least 1 day per week The Regulatory Affairs Specialist is responsible for supporting Regulatory activities which lead to, and maintain, regulatory compliance and approval for products globally. Duties and Responsibilities Perform gap analyses between new/revised regulations and standards and the Quality...

  • Senior Regulatory Affairs Specialist

    4 weeks ago

    Santa Clarita, United States BioTalent Full time

    *Hybrid on-site role in Valencia, CA - at least 1 day per week The Regulatory Affairs Specialist is responsible for supporting Regulatory activities which lead to, and maintain, regulatory compliance and approval for products globally. Duties and Responsibilities Perform gap analyses between new/revised regulations and standards and the Quality...

  • 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 Associate II

    2 days ago

    Santa Clara, California, United States Abbott Full time

    About AbbottAbbott is a leading global healthcare organization dedicated to enhancing the quality of life for individuals at every stage of their health journey. Our diverse portfolio includes innovative technologies across diagnostics, medical devices, nutritionals, and branded generic medicines, supported by a workforce of 114,000 professionals in over 160...

  • Senior Regulatory Affairs Specialist

    1 month ago

    Santa Clarita, United States BioTalent Full time

    *Hybrid on-site role in Valencia, CA - at least 1 day per week The Regulatory Affairs Specialist is responsible for supporting Regulatory activities which lead to, and maintain, regulatory compliance and approval for products globally. Duties and Responsibilities Perform gap analyses between new/revised regulations and standards and the Quality Management...

  • Senior Regulatory Affairs Specialist

    1 month ago

    Santa Clarita, United States BioTalent Full time

    *Hybrid on-site role in Valencia, CA - at least 1 day per week The Regulatory Affairs Specialist is responsible for supporting Regulatory activities which lead to, and maintain, regulatory compliance and approval for products globally. Duties and Responsibilities Perform gap analyses between new/revised regulations and standards and the Quality Management...

  • 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...

  • 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...

  • 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...

  • Quality Assurance and Regulatory Compliance Expert

    2 days ago

    Santa Clara, California, United States Intellectt Inc Full time

    Position: Senior Quality/Regulatory Affairs SpecialistCompany: Intellectt IncRole Overview:We are seeking a highly skilled professional to support our regulatory affairs team with a focus on quality and compliance. This role requires a deep understanding of quality systems and regulatory processes within the medical device sector.Key Responsibilities:Provide...

Senior Regulatory Affairs Specialist

2 months ago

Santa Clara, United States Collabera Full time

We are seeking a detail-oriented and highly motivated Regulatory Affairs Specialist to join our team. This role requires extensive experience with regulatory affairs (RA) submissions, including EU and MU submissions, as well as excellent writing and communication skills. The ideal candidate will have a Bachelor's degree in engineering or science and a minimum of 3 years of experience in regulatory affairs.

Key Responsibilities: Regulatory Submissions:

Prepare and submit technical documents for various countries and government agencies, including the US. This includes formatting up to 200 pages of documentation. Registrations:

Train to handle registrations. Documentation:

Complete and maintain technical documentation, including EU MDR Technical Documentation and CE Technical Documentation preparation. Regulatory Strategy:

Assist in the definition and implementation of regulatory strategy and priorities in conjunction with management, peers, commercial, and affiliate personnel. Communication:

Communicate regulatory issues to management through project management tracking and issue briefings. Ensure effective verbal and written communication, including the ability to negotiate, influence, and manage conflict. Project Management:

Track and manage broad and strategic projects, ensuring timely completion of regulatory strategies and issues. Provide scientific substantiation for product claims and label material activities. Stakeholder Engagement:

Work constructively and collegially with internal customers (scientists, marketing, quality assurance, product development, affiliates) to solve problems and communicate regulatory needs.

Qualifications: Education:

Bachelor's degree in engineering or science required. Master’s degree preferred. Experience:

Minimum of 3 years of Regulatory Affairs experience.

Skills and Competencies: Regulatory Knowledge:

Knowledge of US and/or Canadian regulations, as well as EU and other international medical device regulations related to product and/or device submissions. Hands-on Experience:

Experience with 510(k) submission, PMA/s, US Annual report, CE Technical Documentation preparation, PMA, and IDE submission. Regulatory Compliance:

Knowledge of US and/or Canadian, EU regulations relating to product and/or device clearance (FDA). International Registrations:

Ability to prepare and submit products for international registration. Communication:

High level of effective verbal and written communication skills, including the ability to negotiate, influence, and manage conflict. Teamwork:

Demonstrated ability to work effectively in a team environment. Preferred Experience:

Prior regulatory experience in the medical device, food, dietary supplement, or pharmaceutical industry is strongly preferred, but not required.

#J-18808-Ljbffr