Abbott Laboratories
Regulatory Affairs Specialist II
Abbott Laboratories, Pleasanton, California, United States, 94566
Overview
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio spans 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. 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 – an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries 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 as well as a best place to work for diversity, working mothers, female executives, and scientists. Abbott’s medical device businesses offer technologies that are faster, more effective, and less invasive. Our devices—such as glucose monitoring systems and therapies for heart disease—help people live healthier lives. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands with chronic pain or movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks. What you’ll do
We are recruiting for a
Regulatory Affairs Specialist II
to join our team in Pleasanton, CA. In this role, you will provide support for the regulatory department to ensure efficient and compliant business processes and environment. You will partner across business functions, assist in identifying data needed, obtain required documentation, and ensure that submissions are effectively presented for the registration of products worldwide. You may prepare and/or submit 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 regulatory agencies, ensuring communications are germane, specific and convey all necessary detail. Maintains ongoing surveillance and analysis of international medical device regulations to ensure submission requirements are current; enters information into regulatory submission databases and file systems; distributes new or modified regulations to appropriate personnel. Interfaces directly with regulatory agencies as needed. Conducts reviews of product and manufacturing changes for compliance with applicable regulations. Maintains productive relationships with external customers and regulatory authorities and notified bodies as required. 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 collaborative communications with all levels of staff, customers, contractors, and vendors. Required Qualifications
Bachelors Degree (±16 years) in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred OR equivalent combination of education and work experience. Master's Degree (±18 years), Preferred. Minimum 2 years of experience in a regulated industry (e.g., medical products, nutritionals) is acceptable; regulatory experience is not required but preferred. Other related areas may be considered. Experience with Regulatory history, guidelines, policies, standards, and regulatory agencies; knowledge of GxPs, domestic and international regulatory guidelines, and ethical guidelines of the regulatory profession. Effective verbal and written communication; ability to write and edit technical documents. Ability to work with cross-functional teams and diverse disciplines and cultures. Strong attention to detail; ability to manage projects, create plans and timelines. Analytical and critical thinking; ability to organize and track complex information. Judgment within generally defined practices and the ability to select appropriate methods for solutions; awareness of business impact of regulatory decisions. Business and regulatory ethical standards. Preferred Qualifications
Bachelor’s degree in a technical discipline. 3+ years of related regulatory submission experience in medical devices and/or pharmaceuticals. Familiar with US/EU regulatory requirements for medical devices including Quality Systems standards and clinical investigations. Proficient with MS Office (Word, Excel, Outlook). Strong verbal and written communications; ability to communicate at multiple levels. Advanced degree preferred. Experience in a highly matrixed, geographically diverse 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 for new employees 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. The stability of a company with a track 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. The base pay for this position is $79,500.00 – $138,700.00. In specific locations, the pay range may vary from the range posted.
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Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio spans 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. 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 – an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries 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 as well as a best place to work for diversity, working mothers, female executives, and scientists. Abbott’s medical device businesses offer technologies that are faster, more effective, and less invasive. Our devices—such as glucose monitoring systems and therapies for heart disease—help people live healthier lives. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands with chronic pain or movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks. What you’ll do
We are recruiting for a
Regulatory Affairs Specialist II
to join our team in Pleasanton, CA. In this role, you will provide support for the regulatory department to ensure efficient and compliant business processes and environment. You will partner across business functions, assist in identifying data needed, obtain required documentation, and ensure that submissions are effectively presented for the registration of products worldwide. You may prepare and/or submit 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 regulatory agencies, ensuring communications are germane, specific and convey all necessary detail. Maintains ongoing surveillance and analysis of international medical device regulations to ensure submission requirements are current; enters information into regulatory submission databases and file systems; distributes new or modified regulations to appropriate personnel. Interfaces directly with regulatory agencies as needed. Conducts reviews of product and manufacturing changes for compliance with applicable regulations. Maintains productive relationships with external customers and regulatory authorities and notified bodies as required. 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 collaborative communications with all levels of staff, customers, contractors, and vendors. Required Qualifications
Bachelors Degree (±16 years) in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred OR equivalent combination of education and work experience. Master's Degree (±18 years), Preferred. Minimum 2 years of experience in a regulated industry (e.g., medical products, nutritionals) is acceptable; regulatory experience is not required but preferred. Other related areas may be considered. Experience with Regulatory history, guidelines, policies, standards, and regulatory agencies; knowledge of GxPs, domestic and international regulatory guidelines, and ethical guidelines of the regulatory profession. Effective verbal and written communication; ability to write and edit technical documents. Ability to work with cross-functional teams and diverse disciplines and cultures. Strong attention to detail; ability to manage projects, create plans and timelines. Analytical and critical thinking; ability to organize and track complex information. Judgment within generally defined practices and the ability to select appropriate methods for solutions; awareness of business impact of regulatory decisions. Business and regulatory ethical standards. Preferred Qualifications
Bachelor’s degree in a technical discipline. 3+ years of related regulatory submission experience in medical devices and/or pharmaceuticals. Familiar with US/EU regulatory requirements for medical devices including Quality Systems standards and clinical investigations. Proficient with MS Office (Word, Excel, Outlook). Strong verbal and written communications; ability to communicate at multiple levels. Advanced degree preferred. Experience in a highly matrixed, geographically diverse 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 for new employees 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. The stability of a company with a track 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. The base pay for this position is $79,500.00 – $138,700.00. In specific locations, the pay range may vary from the range posted.
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