- 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.
-
Regulatory Affairs Specialist
3 weeks ago
Abbott Laboratories company Alameda, United StatesRegulatory Affairs Specialist – APAC - Diabetes Care (on-site) page is loaded · Regulatory Affairs Specialist – APAC - Diabetes Care (on-site) · Apply · locations · United States - California - Alameda · time type · Full time · posted on · Posted 3 Days Ago · job requisi ...
-
Regulatory Affairs Specialist
3 weeks ago
Abbott Alameda, United StatesJob Description · Working at Abbott · At 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 d ...
-
Regulatory Affairs Specialist
2 weeks ago
Abbott Alameda, United StatesAbbott 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 medic ...
-
Regulatory Affairs Specialist
2 weeks ago
Abbott Laboratories company Alameda, United StatesAbbott 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 medic ...
-
Regulatory Affairs Specialist
3 weeks ago
Abbott Alameda, United StatesJob Description · Working at Abbott · At 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 d ...
-
Regulatory Affairs Specialist
3 weeks ago
Abbott Alameda, United StatesAbbott 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 medic ...
-
Senior Regulatory Affairs Specialist
2 weeks ago
Abbott Alameda, United StatesAbbott 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 medic ...
-
Senior Regulatory Affairs Specialist
1 week ago
Abbott Laboratories company Alameda, United StatesAbbott 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 medic ...
-
Senior Regulatory Affairs Specialist
1 week ago
Abbott Alameda, United StatesAbbott 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 medic ...
-
Senior Regulatory Affairs Specialist
3 weeks ago
Abbott Alameda, United StatesJob 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 bra ...
-
Regulatory Affairs Specialist II
1 week ago
Abbott Laboratories company Alameda, United StatesAbbott 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 medic ...
-
Regulatory Affairs Specialist
3 weeks ago
Abbott Alameda, United StatesAbbott 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 medic ...
-
Regulatory Affairs Specialist II APAC
5 days ago
Abbott Laboratories company Alameda, United StatesAbbott 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 medic ...
-
Regulatory Affairs Specialist II – APAC
5 days ago
Abbott Laboratories Alameda, United StatesAbbott 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 medic ...
-
Abbott Laboratories company Alameda, United StatesAbbott 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 medic ...
-
Abbott Alameda, United StatesAbbott 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 medic ...
-
Regulatory Affairs Specialist APAC
3 weeks ago
Abbott Laboratories company Alameda, United StatesAbbott 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 medic ...
-
Regulatory Affairs Specialist II
3 weeks ago
Abbott Alameda, United StatesJob 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 bra ...
-
Regulatory Affairs Specialist
1 week ago
Laborie Medical Technologies Corp West Valley City, United StatesWe believe that great healthcare is an essential safeguard of human dignity. · At Laborie, we know the work we do matters - it's what fuels our motivation and contributes to our success. If you're ready to make a positive impact in the lives of patients across the globe, we'd li ...
-
Regulatory Affairs Specialist
2 weeks ago
Integration International Inc. Fremont, United StatesPosition Summary: · Looking for an experienced Labeling Specialist to create and revise labeling components for In Vitro Diagnostic (IVD) products and related documentation regulated by the FDA and ISO · This position requires a person who is detail-oriented, can manage multipl ...
Senior Regulatory Affairs Specialist - Alameda, United States - Abbott Laboratories
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 Abbott
At 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.
ABOUT LINGO
Meet Lingo, a new biosensing technology that provides users a window into their body.
Lingo tracks key biomarkers – such as glucose, ketones, and lactate – to help people make better decisions about their health and nutrition.
Biowearable technology will digitize, decentralize and democratize healthcare, enabling consumers to take control of their own health.A New Category of
Consumer Biowearables:
Meet Lingo - YouTube
THE OPPORTUNITY
Personalized healthcare is the future.
Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance.
The Lingo team embodies a start-up culture and mindset with the backing of Abbott, a company with a rich history of healthcare innovation.
Join us and grow your career as you help Abbott shape the future of healthcare.As an individual contributor, the
Senior Regulatory Affairs Specialist
will support product development and regulatory activities to commercialize products in the US on-site at our Alameda, CA location.
In this role, you will provide regulatory input on design and development activities to cross-functional teams, including software development and systems engineering members, and ensure availability of documentation to support submission activities to meet program objectives and timelines.
This is an exciting opportunity at Lingo.What You'll Work On
Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for Class II software medical devices
Assess the acceptability of documentation for medical device submissions and effectively communicate regulatory guidance
Prepares robust regulatory applications/submissions to regulatory authorities.
Assist in SOP development and review in support of "next-gen" product offerings.
Evaluate proposed design, labeling, and distribution changes for regulatory impact and implement any required regulatory action
Utilize technical regulatory skills to propose strategies on complex issues
Ensure compliance with product post marketing requirements
Review product labeling to ensure compliance with relevant regulatory requirements.
Individual may provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees.
Establishes and cultivates an extensive network of support to facilitate completion of assignments.
Influences middle management on technical or business solutions.
Required Qualifications
Bachelor's Degree; preferably in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, etc.
Minimum 2 yrs. regulatory experience and or 2 years relevant industrial experience typically with a quality; product-development/support; scientific affairs function.
Preferred
Qualifications
Advanced degree in Engineering, Sciences, or related discipline.
Previous experience with 510(k)/PMA submissions or class I / II exempt software devices
Experience with software medical devices
4-6 years' experience in a regulated industry. Regulatory area is preferred but may consider quality assurance, software or systems research and development, or related area.
Ability to work effectively on cross-functional teams.
Must be able to juggle multiple and competing priorities
Ability to identify and solve problems and work independently with little oversight.
Strong written, verbal, presentation, and organizational skills.
Working knowledge of FDA QSR.
Has a sound knowledge of a variety of alternatives and their impact on the business.
Apply Now
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
Connect with us at
, on Facebook at
and on Twitter @AbbottNews. Connect with us at
, on Facebook at
and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is $83,600.00 – $167, In specific locations, the pay range may vary from the range posted.
