Regulatory Affairs Specialist I

Company: Abbott Laboratories
Location: Santa Clara
Posted on: November 22, 2021

Job Description:

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 109,000 colleagues serve people in more than 160 countries.Regulatory Affairs Specialist I - Santa Clara, CA ABOUT ABBOTT Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of STRUCTURAL HEART disease. We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care. WHAT YOU'LL DO We are recruiting for a Regulatory Affairs Specialist II to join our team in the Santa Clara, CA location. In this role, you will be responsible for coordinating and support technical and scientific regulatory activities, research regulations and guidance, and maintain and organize key information sources. Responsibilities:

• Provides support for regulatory processes and procedures
• Maintains current registrations by preparing documentation required and submitting documentation on schedule as directed
• Review change orders and assesses worldwide regulatory impact of manufacturing or product changes. Review and approve labeling changes to ensure compliance with regulatory requirements
• Review technical documentation in order to comply with regulatory/MDR requirements. Prepare and maintain technical files and design dossiers in compliance with MDR. Additionally, may prepare and submit US PMA supplements EDUCATION AND EXPERIENCE YOU'LL BRING Required
  • Bachelor's Degree in Science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), Math, Engineering, or related discipline
  • 2+ years of similar experience from a regulated industry (i.e. medical device, pharmaceutical, aerospace, etc)
  • Demonstrated experience reviewing and analyzing documentation
  • Proficient with MS Office suite (Word, Excel, Outlook)
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organizationPreferred
    • Advanced level degree
    • Medical device experience
    • Experience with 510(k) applications, PMA supplements and US device regulations and/or experience with EU and other international medical device regulations and submissions WHAT WE OFFER At Abbott, you can have a good job that can grow into a great career. We offer:
      • Training and career development, with onboarding programs for new employees and tuition assistance
      • Financial security through competitive compensation, incentives and retirement plans
      • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
      • Paid time off
      • 401(k) retirement savings with a generous company match
      • The stability of a company with a record of strong financial performance and history of being actively involved in local communities Learn more about our benefits that add real value to your life to help you live fully: Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at , on Facebook at and on

Keywords: Abbott Laboratories, Santa Clara , Regulatory Affairs Specialist I, Other , Santa Clara, California