Regulatory Affairs Specialist II - Heart Failure
Company: Abbott Laboratories
Location: Pleasanton
Posted on: November 17, 2023
Job Description:
Regulatory Affairs Specialist II - Heart Failure page is loaded
Regulatory Affairs Specialist II - Heart Failure Apply locations
United States - California - Pleasanton time type Full time posted
on Posted 4 Days Ago job requisition id 31069639 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 115,000 colleagues serve people in more than 160
countries.JOB DESCRIPTION: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. You'll also have access
to:
- Career development with an international company where you can
grow the career you dream of.
- Free medical coverage for employees* via the Health Investment
Plan (HIP) PPO
- An excellent retirement savings plan with high employer
contribution
- Tuition reimbursement, the Freedom 2 Save student debt program
and FreeU education benefit - an affordable and convenient path to
getting a bachelor's degree.
- A company recognized as a great place to work in dozens of
countries around the world and named one of the most admired
companies in the world by Fortune.
- A company that is recognized as one of the best big companies
to work for as well as a best place to work for diversity, working
mothers, female executives, and scientists.The Opportunity We are
presently hiring for a Regulatory Affairs Specialist II to join our
Heart Failure division in Pleasanton, CA. This new team member will
perform 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. - Additionally, will
support necessary regulatory activities required for product market
entry. What You'll Work On
- Prepares robust regulatory applications (either for FDA or for
international regulatory agencies) to achieve departmental and
organizational objectives.
- Creates, reviews and approves engineering changes.
- Acts as core team member providing review and analysis of
applicable regulatory guidelines and project regulatory assessments
as needed.
- Reviews and evaluates communications to ensure communications
convey all necessary detail and adhere to applicable regulatory
standards including those set by the FDA 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.
- May interface directly with FDA and other regulatory
agencies.
- Supports the product release process by creating GTS licenses
or reviewing and approving requests for product release.
- Reviews protocols and reports to support regulatory
submissions.
- Supports all business segment initiatives as identified by
divisional 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.
Required Qualifications
- Bachelor's degree or an equivalent combination of education and
work experience
- Minimum 3 years' related experience, including a minimum of two
years regulatory experience
- Experience with either 510(k) applications, PMA supplements and
US device regulations or with EU and other international medical
device regulations and submissions.
- 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.
- Strong verbal and written communications with ability to
effectively communicate at multiple levels in the organization.
-
- Multitasks, prioritizes and meets deadlines in timely
manner.
- Strong organizational and follow-up skills, as well as
attention to detail. Preferred Qualifications
- Bachelor's degree in a technical discipline. -
- Experience working in a broader enterprise/cross-division
business unit model
- Certification is a plus (such as RAC from the Regulatory
Affairs Professionals Society.) * Participants who complete a short
wellness assessment qualify for FREE coverage in our HIP PPO
medical plan. Free coverage applies in the next calendar year.Learn
more about our health and wellness benefits, which provide the
security to help you and your family live full lives:
www.abbottbenefits.com Follow your career aspirations to Abbott for
diverse opportunities with a company that can help you build your
future and live your best life. Abbott is an Equal Opportunity
Employer, committed to employee diversity.Connect with us at
www.abbott.com , on Facebook at www.facebook.com/Abbott and on
Twitter @AbbottNews. Connect with us at www.abbott.com , on
Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and
@AbbottGlobal. The base pay for this position is$65,200.00 -
$130,400.00 In specific locations, the pay range may vary from the
range posted. JOB FAMILY:Regulatory OperationsDIVISION:HF Heart
FailureLOCATION:United States > Pleasanton : 6101 Stoneridge
DrADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:Yes, 5 % of the
TimeMEDICAL SURVEILLANCE:NoSIGNIFICANT WORK ACTIVITIES:
Awkward/forceful/repetitive (arms above shoulder, bent wrists),
Continuous sitting for prolonged periods (more than 2 consecutive
hours in an 8 hour day)Abbott is an Equal Opportunity Employer of
Minorities/Women/Individuals with Disabilities/Protected
Veterans.EEO is the Law link - English:
http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is
the Law link - Espanol:
http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
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Posted Yesterday About Us Abbott - is about the power of health.
For more than 125 years, - Abbott - has been helping people reach
their potential - because better health allows people and
communities to achieve more. With a diverse, global network serving
customers in more than 160 countries, we create new solutions -
across the spectrum of health, around the world, for all stages of
life. Whether it's next-generation diagnostics, life-changing
devices, science-based nutrition, or novel reformulations, we are
advancing some of the most innovative and revolutionary
technologies in healthcare, helping people live their best lives
through better health. The people of - Abbott - come to work each
day with relentless energy, enthusiasm and a promise to enhance the
health and well-being of millions of people. They push the
boundaries to help manage and treat some of life's greatest health
challenges.We invite you to explore opportunities at - Abbott , to
see if your talents and career aspirations may fit with our
openings. An equal opportunity employer, - Abbott - welcomes and
encourages diversity in our workforce.Follow Us:Facebook LinkedIn
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Keywords: Abbott Laboratories, Pleasanton , Regulatory Affairs Specialist II - Heart Failure, Other , Pleasanton, California
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