Abbott
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.
Overview 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.
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
An excellent retirement savings plan with high employer contribution; tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit.
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 recognized as one of the best big companies to work for and 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, 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 living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingerticks.
What You’ll Do We are recruiting for a
Regulatory Affairs Specialist II
to join our team in the Pleasanton, CA location. In this role, you will provide support for the regulatory department to ensure efficient and compliant business processes and environment. You will play a consultative role by partnering across business functions, assisting in identifying data needed, obtaining required documentation, and ensuring that submissions are effectively presented for the registration of products worldwide. You may be preparing and/or submitting documentation needed for worldwide registration.
Responsibilities
Authors, coordinates, compiles and submits international regulatory submissions, including filing and/or creation of Technical Documentation, Premarket Notifications, Supplements, Change Notifications, and other product registrations.
Prepares robust regulatory applications to achieve departmental and organizational objectives.
Represents RA on cross-functional product development and manufacturing support teams.
Acts as liaison between the Company and the various regulatory agencies, ensuring communications are germane, specific and detailed.
Maintains surveillance and analysis of international medical device regulations to ensure submission requirements are current; updates regulatory submission data bases and file systems; disseminates changes to appropriate personnel.
Interfaces directly with regulatory agencies as needed.
Conducts reviews of product and manufacturing changes for compliance.
Maintains productive relationships with external customers as required – regulatory authorities and notified bodies.
Supports Department and Company initiatives in Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Complies with international regulations, company policies, procedures, and task assignments; maintains positive communications with all levels of employees, customers, contractors, and vendors.
Qualifications Required
Bachelor’s Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or related field, or an equivalent combination of education and work experience.
Master’s Degree (preferred).
Minimum of 2 years in a regulated industry (e.g., medical products, nutritionals); regulatory experience preferred but may consider related areas; strong willingness to learn regulatory submission concepts.
Experience with regulatory history, guidelines, standards, submission types and requirements; knowledge of GxPs; familiarity with domestic and international regulatory guidelines and ethical standards.
Effective verbal and written communication; ability to write and edit technical documents; able to work with diverse teams.
Project management skills; strong attention to detail; analytical thinking; ability to organize and track complex information.
Ability to exercise judgment within defined practices and policies; understand business impact of regulatory decisions.
Willingness to work in a highly matrixed and geographically diverse environment.
Preferred
Bachelor’s degree in a technical discipline.
3+ years of regulatory submission experience in medical device and/or pharmaceutical sectors.
Familiarity with US/EU regulatory requirements for medical devices including Quality Systems standards and clinical investigations.
Proficiency with MS Office (Word, Excel, Outlook).
Strong verbal and written communications for multiple organizational levels.
Advanced degree.
Experience in a matrixed, geographically diverse business environment.
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 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.
Stability of a company
with a record of strong financial performance and community involvement.
Learn more about our benefits that add real value to your life to help you live fully:
www.abbottbenefits.com
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.
Base pay:
$79,500.00 – $138,700.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
HF Heart Failure
LOCATION:
United States > Pleasanton: 6035 Stoneridge Dr
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 5% of the Time
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (≥50% of the workday)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law: EEO English and Spanish PDFs available on our site.
#J-18808-Ljbffr
Overview 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.
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
An excellent retirement savings plan with high employer contribution; tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit.
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 recognized as one of the best big companies to work for and 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, 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 living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingerticks.
What You’ll Do We are recruiting for a
Regulatory Affairs Specialist II
to join our team in the Pleasanton, CA location. In this role, you will provide support for the regulatory department to ensure efficient and compliant business processes and environment. You will play a consultative role by partnering across business functions, assisting in identifying data needed, obtaining required documentation, and ensuring that submissions are effectively presented for the registration of products worldwide. You may be preparing and/or submitting documentation needed for worldwide registration.
Responsibilities
Authors, coordinates, compiles and submits international regulatory submissions, including filing and/or creation of Technical Documentation, Premarket Notifications, Supplements, Change Notifications, and other product registrations.
Prepares robust regulatory applications to achieve departmental and organizational objectives.
Represents RA on cross-functional product development and manufacturing support teams.
Acts as liaison between the Company and the various regulatory agencies, ensuring communications are germane, specific and detailed.
Maintains surveillance and analysis of international medical device regulations to ensure submission requirements are current; updates regulatory submission data bases and file systems; disseminates changes to appropriate personnel.
Interfaces directly with regulatory agencies as needed.
Conducts reviews of product and manufacturing changes for compliance.
Maintains productive relationships with external customers as required – regulatory authorities and notified bodies.
Supports Department and Company initiatives in Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Complies with international regulations, company policies, procedures, and task assignments; maintains positive communications with all levels of employees, customers, contractors, and vendors.
Qualifications Required
Bachelor’s Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or related field, or an equivalent combination of education and work experience.
Master’s Degree (preferred).
Minimum of 2 years in a regulated industry (e.g., medical products, nutritionals); regulatory experience preferred but may consider related areas; strong willingness to learn regulatory submission concepts.
Experience with regulatory history, guidelines, standards, submission types and requirements; knowledge of GxPs; familiarity with domestic and international regulatory guidelines and ethical standards.
Effective verbal and written communication; ability to write and edit technical documents; able to work with diverse teams.
Project management skills; strong attention to detail; analytical thinking; ability to organize and track complex information.
Ability to exercise judgment within defined practices and policies; understand business impact of regulatory decisions.
Willingness to work in a highly matrixed and geographically diverse environment.
Preferred
Bachelor’s degree in a technical discipline.
3+ years of regulatory submission experience in medical device and/or pharmaceutical sectors.
Familiarity with US/EU regulatory requirements for medical devices including Quality Systems standards and clinical investigations.
Proficiency with MS Office (Word, Excel, Outlook).
Strong verbal and written communications for multiple organizational levels.
Advanced degree.
Experience in a matrixed, geographically diverse business environment.
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 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.
Stability of a company
with a record of strong financial performance and community involvement.
Learn more about our benefits that add real value to your life to help you live fully:
www.abbottbenefits.com
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.
Base pay:
$79,500.00 – $138,700.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
HF Heart Failure
LOCATION:
United States > Pleasanton: 6035 Stoneridge Dr
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 5% of the Time
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (≥50% of the workday)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law: EEO English and Spanish PDFs available on our site.
#J-18808-Ljbffr