REGULATORY AFFAIRS OPERATIONS SPECIALIST I (ON-SITE)
Company: Abbott Laboratories
Location: Los Angeles
Posted on: September 30, 2024
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 114,000 colleagues
serve people in more than 160 countries.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 student debt program and 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.For years, Abbott's
medical device businesses have offered technologies that are
faster, more effective, and less invasive. Whether it's glucose
monitoring system, innovative therapies for treating heart disease,
or products that help people with chronic pain or movement
disorders, our medical device technologies are designed to help
people live their lives better and healthier. Every day, our
technologies help more than 10,000 people have healthier hearts,
improve quality of life for thousands of people living with chronic
pain and movement disorders, and liberate more than 500,000 people
with diabetes from routine ---ngersticks.The Opportunity We are
currently hiring a Regulatory Affairs Operations Specialist I to
work on-site at our Sylmar, CA location. 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
- Daily support of product releases by preparing Global Trade
Services (GTS) licenses for products, countries and business
partners allowing shipment of product to achieve departmental and
organizational objectives.
- Responsible for following SOPs for managing GTS licenses,
additional release authorizations (ARAs) and tender support and
overall regulatory operations activities.
- Have a full working knowledge of GTS license types, country
regulatory and language requirements.
- Provide support for Product and Country Experts in the set-up
for release of new and modified products globally.
- Acts as a regulatory representative responsible for review and
analysis of GTS blocked orders, providing guidance and direction on
regulatory compliance.
- Reviews and evaluates customer service requests and monitoring
of email box for such requests, maintaining a high level of service
and follow through on all communications.
- Ensure communications convey all necessary detail and adhere to
applicable regulatory standards.
- Maintains positive and cooperative communications and
collaboration with all levels of employees worldwide; customers,
contractors, and vendors.
- Have a basic understanding of product lines being
supported.
- Have full understanding of Windchill and SAP applications for
research, problem solving and analysis of blocked orders and
creation of GTS licenses.
- Represent Regulatory Operations in cross-functional
interactions with Supply Chain, Customer Support, Quality,
Marketing, In-Country affiliates and IT.
- 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)
regulations, international regulations and other regulatory
requirements, company policies, operating procedures, processes,
and task assignments.
- Participates in projects affecting GTS licenses and performs
other related duties and responsibilities, as assigned -Required
Qualifications
- Bachelor's Degree OR an equivalent combination of education or
work experience. - -
- 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 with medical device industry.
- Experience working in a broader enterprise/cross-division
business unit model.
- Strong problem solving skills and ability to think
strategically and see the big picture.
- Adaptable with the ability to switch priorities and accomplish
all tasks.
- Process oriented. -* 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: - 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 , on Facebook at and on Twitter
@AbbottNews.
The base pay for this position is $55,200.00 - $110,400.00. In
specific locations, the pay range may vary from the range
posted.
Keywords: Abbott Laboratories, South Gate , REGULATORY AFFAIRS OPERATIONS SPECIALIST I (ON-SITE), Other , Los Angeles, California
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