Abbott Laboratories
Regulatory Affairs Specialist II – Heart Failure
Abbott Laboratories, Pleasanton, California, United States, 94566
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) PPOAn excellent retirement savings plan with high employer contributionTuition 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.Regulatory Affairs Specialist II
will work out of our Pleasanton, CA location in our Heart Failure Division. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives.The OpportunityAs an individual contributor, this position performs 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. This new team member will support necessary regulatory activities required for product market entry.What You’ll Work OnPrepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives.Creates, reviews and approves engineering changes.Acts as core team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed.Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates.Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.May interface directly with FDA and other regulatory agencies.Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.Reviews protocols and reports to support regulatory submissions.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) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.Required QualificationsBachelor’s Degree or an equivalent combination of education and work experienceMinimum 3 years’ related experience, including a minimum of two years regulatory experienceExperience with either 510(k) applications, PMA supplements and US device regulations or with EU and other international medical device regulations and submissions.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, manage and/or engage others to accomplish projects.Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.Strong organizational and follow-up skills, as well as attention to detail.Multitasks, prioritizes and meets deadlines in timely manner.Preferred QualificationsBachelor’s Degree in a Science/Technical discipline (engineering, life sciences, mathematics).Master’s degreeExperience working in a broader enterprise/cross-division business unit model.Experience working in the Medical Device industry.Regulatory Affairs Professionals Society Certification is a plus.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 $65,900.00 – $131,900.00. In specific locations, the pay range may vary from the range posted.
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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.Regulatory Affairs Specialist II
will work out of our Pleasanton, CA location in our Heart Failure Division. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives.The OpportunityAs an individual contributor, this position performs 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. This new team member will support necessary regulatory activities required for product market entry.What You’ll Work OnPrepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives.Creates, reviews and approves engineering changes.Acts as core team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed.Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates.Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.May interface directly with FDA and other regulatory agencies.Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.Reviews protocols and reports to support regulatory submissions.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) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.Required QualificationsBachelor’s Degree or an equivalent combination of education and work experienceMinimum 3 years’ related experience, including a minimum of two years regulatory experienceExperience with either 510(k) applications, PMA supplements and US device regulations or with EU and other international medical device regulations and submissions.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, manage and/or engage others to accomplish projects.Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.Strong organizational and follow-up skills, as well as attention to detail.Multitasks, prioritizes and meets deadlines in timely manner.Preferred QualificationsBachelor’s Degree in a Science/Technical discipline (engineering, life sciences, mathematics).Master’s degreeExperience working in a broader enterprise/cross-division business unit model.Experience working in the Medical Device industry.Regulatory Affairs Professionals Society Certification is a plus.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 $65,900.00 – $131,900.00. In specific locations, the pay range may vary from the range posted.
#J-18808-Ljbffr