Abbott
Senior Regulatory Affairs Specialist
Abbott, Pomona, California, United States, 91768
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.JOB DESCRIPTION:
Senior Regulatory Affairs SpecialistWorking 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 OpportunityThe position of
Senior Regulatory Affairs Specialist
is within our Toxicology Business Unit located in
Pomona, CA . This role is responsible for directing and coordinating the implementation of regulatory compliance programs as required by federal, state, and local government agencies. This includes achieving government registration and licensure approval of new products and assuring that current products and manufacturing operations are in compliance with applicable regulations. You will interact with Marketing, Sales Regional Regulatory Affairs staff, regional distributors, governmental regulatory agencies and other third-party accrediting bodies.What You’ll Work OnProvides regulatory support for commercial in-vitro diagnostic products
Performs regulatory assessment for changes made to the on-market products
Understanding of the US 510(k) and EU CE mark (MDR/IVDR) regulatory requirements
Develops regulatory strategies to achieve clearance/approval internationally (outside United States)
Compiles and publishes all material required for submissions, license renewals, and annual registrations
Works with governmental regulatory agencies and other third-party accrediting bodies
Maintains
approvals/licenses/authorizations
for existing marketing authorizations
Adds and maintains information contained in the Global Regulatory Information Database
Provides recommendations on labeling, for regulatory compliance
Develops internal procedures and tools
Conducts informational or training sessions for stakeholders
Organizes and maintains hard copy and electronic department files
Keeps informed of global regulatory information
Carries out duties in compliance with established business policies
Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices
Demonstrates commitment to the development, implementation and effectiveness of Company Quality Management System per ISO, FDA, and other regulatory agencies
Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities
Performs other duties and projects as assigned
Required QualificationBachelor’s degree (BS/BA) in a scientific field
3-5 years of experience in a regulated industry
Proficient with Microsoft Office, including Word, Excel, PowerPoint and Visio
Able to work on multiple tasks as a team member and/or ability to operate as an individual contributor
Must be detail-orientated, self-motivated and available for flexible scheduling
Strong written and verbal communication, problem solving and motivational skills
Preferred
Qualification3 years of experience in Regulatory Affairs
Three plus years in an IVD or medical device manufacturing environment
510k submission experience
Technical file creation and maintenance experience
Strong knowledge of US and Foreign regulations
Able to work on multiple tasks simultaneously as a team member and/or ability to operate as an individual contributor
Possess a high degree of accuracy, detail-orientated, self-motivated and available for flexible scheduling
Apply Now* 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.comFollow 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.The base pay for this position is$83,600.00 – $167,200.00
In specific locations, the pay range may vary from the range posted.JOB FAMILY:
Regulatory Operations
DIVISION:
TOX ARDx Toxicology
LOCATION:
United States > Pomona : 829 Towne Center Drive
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)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.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf#J-18808-Ljbffr
Senior Regulatory Affairs SpecialistWorking 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 OpportunityThe position of
Senior Regulatory Affairs Specialist
is within our Toxicology Business Unit located in
Pomona, CA . This role is responsible for directing and coordinating the implementation of regulatory compliance programs as required by federal, state, and local government agencies. This includes achieving government registration and licensure approval of new products and assuring that current products and manufacturing operations are in compliance with applicable regulations. You will interact with Marketing, Sales Regional Regulatory Affairs staff, regional distributors, governmental regulatory agencies and other third-party accrediting bodies.What You’ll Work OnProvides regulatory support for commercial in-vitro diagnostic products
Performs regulatory assessment for changes made to the on-market products
Understanding of the US 510(k) and EU CE mark (MDR/IVDR) regulatory requirements
Develops regulatory strategies to achieve clearance/approval internationally (outside United States)
Compiles and publishes all material required for submissions, license renewals, and annual registrations
Works with governmental regulatory agencies and other third-party accrediting bodies
Maintains
approvals/licenses/authorizations
for existing marketing authorizations
Adds and maintains information contained in the Global Regulatory Information Database
Provides recommendations on labeling, for regulatory compliance
Develops internal procedures and tools
Conducts informational or training sessions for stakeholders
Organizes and maintains hard copy and electronic department files
Keeps informed of global regulatory information
Carries out duties in compliance with established business policies
Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices
Demonstrates commitment to the development, implementation and effectiveness of Company Quality Management System per ISO, FDA, and other regulatory agencies
Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities
Performs other duties and projects as assigned
Required QualificationBachelor’s degree (BS/BA) in a scientific field
3-5 years of experience in a regulated industry
Proficient with Microsoft Office, including Word, Excel, PowerPoint and Visio
Able to work on multiple tasks as a team member and/or ability to operate as an individual contributor
Must be detail-orientated, self-motivated and available for flexible scheduling
Strong written and verbal communication, problem solving and motivational skills
Preferred
Qualification3 years of experience in Regulatory Affairs
Three plus years in an IVD or medical device manufacturing environment
510k submission experience
Technical file creation and maintenance experience
Strong knowledge of US and Foreign regulations
Able to work on multiple tasks simultaneously as a team member and/or ability to operate as an individual contributor
Possess a high degree of accuracy, detail-orientated, self-motivated and available for flexible scheduling
Apply Now* 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.comFollow 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.The base pay for this position is$83,600.00 – $167,200.00
In specific locations, the pay range may vary from the range posted.JOB FAMILY:
Regulatory Operations
DIVISION:
TOX ARDx Toxicology
LOCATION:
United States > Pomona : 829 Towne Center Drive
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)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.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf#J-18808-Ljbffr