Regulatory Specialist II

4 weeks ago


Santa Clara, United States HireTalent - Diversity Staffing & Recruiting Firm Full time

Title: Regulatory Specialist II

Location: Santa Clara, CA 95054 (Onsite)

Duration: 12 Months from the start date

Shift Time: 08:00 AM to 5:00 PM

Pay Rate: $45.00/hr. on W2


Duties:

  • Responsible for implementing and maintaining the effectiveness of the quality system.
  • Supports manufacturing/operations day to day activities for change control.
  • Provides market support in terms of change control and product development.
  • Provides regulatory direction/interpretation on team activities. Interprets and applies regulatory understanding to support of products and teams.
  • Prepares U.S and EU regulatory submissions and/or registration documents for international affiliates and government agencies worldwide.
  • Handles regulatory activities involved in documentation, labeling, field support.
  • Applies regulatory and technical knowledge to a wide variety of complex work assignments.
  • Maintains and ensures compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports.
  • Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.

Requirement:

  • 2 years regulatory experience preferably with medical devices:
  • Knowledge of regulations and standards of medical devices.

Education:

  • BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.



  • Santa Clara, United States Actalent Full time

    Job Title: Regulatory Specialist IIJob Description We are seeking a Regulatory Specialist II with 2-5 years of regulatory experience and/or 2 years of relevant industrial experience, typically within a quality product-development/support or scientific affairs function. The ideal candidate will have a strong understanding of regulations and standards...


  • santa clara, United States TalentBurst Full time

    Job Title: Regulatory Specialist II Location: Santa Clara, CA Duration: 12 Months Years Experience: 2-5 years regulatory experience and/or 2 years relevant industrial experience typically with a quality, product-development/support, or scientific affairs function Skills: Knowledge of regulations and standards affecting IVDs and/or biologics Education: BS...


  • Santa Clara, United States Talentburst Full time

    Job Title: Regulatory Specialist IIFind out more about this role by reading the information below, then apply to be considered. Location: Santa Clara, CA Duration: 12 Months Years Experience: 2-5 years regulatory experience and/or 2 years relevant industrial experience typically with a quality, product-development/support, or scientific affairs function ...

  • Regulatory Specialist

    4 weeks ago


    Santa Clara, United States TalentBurst, an Inc 5000 company Full time

    Position: Regulatory Specialist II, Req#: ABOJP00037997Location: Santa Clara, CA (100% onsite)Duration: 12+ Months ContractJob Description:Education and Experience:BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.2-5 years of regulatory experience and/or 2 years relevant industrial experience...


  • Santa Clara, California, United States Abbott Laboratories Full time

    Company OverviewAbbott Laboratories is a leading global healthcare company that focuses on developing innovative medical devices and treatments to improve patients' lives.We are committed to delivering high-quality products and services while ensuring compliance with regulatory requirements.SalaryThe estimated annual salary for this position is $95,400 -...


  • santa clara, United States HireTalent - Diversity Staffing & Recruiting Firm Full time

    Title: Regulatory Specialist IILocation: Santa Clara, CA 95054 (Onsite)Duration: 12 Months from the start dateShift Time: 08:00 AM to 5:00 PMPay Rate: $45.00/hr. on W2Duties:Responsible for implementing and maintaining the effectiveness of the quality system.Supports manufacturing/operations day to day activities for change control.Provides market support in...


  • santa clara, United States HireTalent - Diversity Staffing & Recruiting Firm Full time

    Title: Regulatory Specialist IILocation: Santa Clara, CA 95054 (Onsite)Duration: 12 Months from the start dateShift Time: 08:00 AM to 5:00 PMPay Rate: $45.00/hr. on W2Duties:Responsible for implementing and maintaining the effectiveness of the quality system.Supports manufacturing/operations day to day activities for change control.Provides market support in...


  • Santa Clarita, California, United States Boston Scientific Full time

    About the Position:As a Regulatory Affairs Specialist II at Boston Scientific, you will play a crucial role in ensuring the company's products meet regulatory requirements worldwide. This is a hybrid position that requires minimum three days of office work per week, with a preferred location in Valencia, CA, and flexibility to be located in other US BSC...


  • Santa Clara, California, United States Abbott Laboratories Full time

    Company Overview">Abbott Laboratories is a global healthcare leader that helps people live more fully at all stages of life. With a portfolio of life-changing technologies spanning the spectrum of healthcare, our company offers leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.">Salary Range">The...


  • Santa Clara, California, United States Kaiser Permanente Full time

    Job Title: Home Health Care Specialist IILocation: Santa Clara, CaliforniaAbout the Role:We are seeking a skilled and compassionate Home Health Nurse II to join our team at Kaiser Permanente. As a vital member of our healthcare team, you will provide high-quality care to patients in their place of residence, promoting health, comfort, and...


  • Santa Clara, California, United States Abbott Laboratories Full time

    Regulatory Affairs Manager Role at Abbott LaboratoriesAt Abbott Laboratories, we're committed to helping 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.We're seeking a...


  • Santa Clara, California, United States Abbott Laboratories Full time

    About Abbott LaboratoriesAbbott is a global healthcare leader that empowers individuals to live their best lives. Our diverse portfolio of innovative technologies and solutions spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and pharmaceuticals.OverviewWe are committed to delivering...


  • Santa Clara, California, United States Shockwave Medical Full time

    Job DescriptionAt Shockwave Medical, Inc., we are a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease.We aim to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through our differentiated and proprietary local delivery of...


  • 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...


  • 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...


  • 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...


  • 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...


  • 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...


  • 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...


  • 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...