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Senior Regulatory Affairs Specialist

Company: Abbott Laboratories
Location: Pleasanton
Posted on: May 4, 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.Leading an active lifestyle is important to the many people we serve. In Abbott's ELECTROPHYSIOLOGY & HEART FAILURE division, we're advancing the treatment of heart and vascular disease through breakthrough medical technologies in EP/HF, allowing people to restore their health and get on with their lives. WHAT YOU'LL DOThis position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry

  • Prepares robust regulatory applications/submissions and technical file documentation (either for FDA, Notified Bodies or for international regulatory agencies) to achieve departmental and organizational objectives.
  • Conducts reviews of product and manufacturing changes for compliance with applicable regulations.
  • Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team. Provides guidance and expertise.
  • Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA, Notified Bodies or other worldwide regulatory agencies to various international affiliates.
  • Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.
  • Independently interacts and builds partnership with FDA and Notified Bodies (primarily in the US and EU).
  • Work with cross-functional team to support product release process.
  • Reviews protocols and reports to support regulatory submissions.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Performs other related duties and responsibilities, on occasion, as assigned EDUCATION & EXPERIENCE YOU'LL BRING
    • BA or BS degree in a technical discipline.
    • Minimum 5 years of regulatory experience with medical devices; experience with Class III medical devices highly preferred.
    • Experience with either 510(k) applications, IDEs, PMA or PMA supplements and US device regulations and experience with EU submission and other international medical device regulations and submissions; EU MDR submission experience highly preferred.
    • Must be familiar with regulatory requirement for medical devices in the US and EU (at a minimum) including Quality Systems and ISO standards.
    • Strong verbal and written communication skills with the ability to effectively communicate at multiple levels in the organization,
    • Ability to identify and solve problems and work independently with little oversight.
    • Experience working in a broader enterprise/cross-division business unit model preferred.
    • Ability to work in a highly matrixed and geographically diverse business environment.
    • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
    • Ability to leverage and/or engage others to accomplish projects.
    • Multitasks, prioritizes and meets deadlines in timely manner.
    • Strong organizational and follow-up skills, as well as attention to detail.
    • Ability to travel approximately 5%, including internationally.
    • Ability to maintain regular and predictable attendance. 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, Pleasanton , Senior Regulatory Affairs Specialist, Other , Pleasanton, California

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