Abbott
Senior International Regulatory Product Specialist – Diabetes Care (on-site)
Abbott, Alameda, California, United States, 94501
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:
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.At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That’s why we’re focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.The OpportunityThis
Senior International Regulatory Operations Specialist
will work on-site at our Alameda, CA location in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.As an individual contributor, the Senior Specialist will provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and play a consultative role by partnering across business functions. This new team member assists in identifying emerging regulations, interpreting them and ensuring that they are effectively presented to different stakeholders across the organization. Additionally, may prepare and submit documentation needed for registration worldwide or may oversee such preparation.What You’ll Work OnAssist in SOP development and reviewProvide regulatory input to product lifecycle planning.Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.Understand, investigate, and evaluate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval.Determine trade issues to anticipate regulatory obstacles.Determine and communicate submission and approval requirements.Participate in risk benefit analysis for regulatory compliance.Assess the acceptability of documentation for gap assessments submitted.Monitor impact of changing regulations on submission strategies.Maintain annual licenses, registrations, listings and patent information.Assist compliance with product post-marketing approval requirements.Assess external communications relative to regulations.Review regulatory aspects of contracts.Assist with label development and review for compliance before release.Contribute to the development and functioning of the crisis/ issue management program.Provide regulatory input for product recalls and recall communications.Required QualificationsBachelor’s degree3-4 years’ experience in a regulated industry (e.g., medical products, nutritionals, Pharma). Note: Higher education may compensate for years of experience.Regulatory history, guidelines, policies, standards, practices, requirements and precedentsRegulatory agency structure, processes and key personnelPrinciples and requirements of applicable product lawsSubmission/registration types and requirements GxPs (GCPs, GLPs, GMPs)International treaties and regional, national, local and territorial trade requirements, agreements and considerationsDomestic and international regulatory guidelines, policies and regulationsEthical guidelines of the regulatory profession, clinical research and regulatory processPay strong attention to detail, think analytically and organize and track complex informationManage projects and create project plans and timelinesExercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining resultsHas broad knowledge of various technical alternatives and their potential impact on the businessExercise good and ethical judgment within policy and regulationsUse in-depth knowledge of business functions and cross group dependencies/ relationshipsDefine regulatory strategy with supervisionFollow scientific arguments, identify regulatory scientific data needs and with supervision solve regulatory issuesPreferred
QualificationsBachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, engineering, scientific affairs, operations, or related area.Advanced level degreeExperience with EU and other international medical device / drugs / pharma regulations and submissions.Experience with design controls in medical devices, IVDR, Pharma industriesProficient with Excel and PowerPoint and presenting information to leadershipPrevious experience working in a highly matrixed and geographically diverse business environmentStrong verbal and written communications with ability to effectively communicate at multiple levels in the organization.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. Connect with us at
www.abbott.com
, on Facebook at
www.facebook.com/Abbott
and on Twitter @AbbottNews and @AbbottGlobal.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:
ADC Diabetes Care
LOCATION:
United States > Alameda : 2901 Harbor Bay Parkway
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 5 % of the Time
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)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
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.At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That’s why we’re focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.The OpportunityThis
Senior International Regulatory Operations Specialist
will work on-site at our Alameda, CA location in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.As an individual contributor, the Senior Specialist will provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and play a consultative role by partnering across business functions. This new team member assists in identifying emerging regulations, interpreting them and ensuring that they are effectively presented to different stakeholders across the organization. Additionally, may prepare and submit documentation needed for registration worldwide or may oversee such preparation.What You’ll Work OnAssist in SOP development and reviewProvide regulatory input to product lifecycle planning.Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.Understand, investigate, and evaluate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval.Determine trade issues to anticipate regulatory obstacles.Determine and communicate submission and approval requirements.Participate in risk benefit analysis for regulatory compliance.Assess the acceptability of documentation for gap assessments submitted.Monitor impact of changing regulations on submission strategies.Maintain annual licenses, registrations, listings and patent information.Assist compliance with product post-marketing approval requirements.Assess external communications relative to regulations.Review regulatory aspects of contracts.Assist with label development and review for compliance before release.Contribute to the development and functioning of the crisis/ issue management program.Provide regulatory input for product recalls and recall communications.Required QualificationsBachelor’s degree3-4 years’ experience in a regulated industry (e.g., medical products, nutritionals, Pharma). Note: Higher education may compensate for years of experience.Regulatory history, guidelines, policies, standards, practices, requirements and precedentsRegulatory agency structure, processes and key personnelPrinciples and requirements of applicable product lawsSubmission/registration types and requirements GxPs (GCPs, GLPs, GMPs)International treaties and regional, national, local and territorial trade requirements, agreements and considerationsDomestic and international regulatory guidelines, policies and regulationsEthical guidelines of the regulatory profession, clinical research and regulatory processPay strong attention to detail, think analytically and organize and track complex informationManage projects and create project plans and timelinesExercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining resultsHas broad knowledge of various technical alternatives and their potential impact on the businessExercise good and ethical judgment within policy and regulationsUse in-depth knowledge of business functions and cross group dependencies/ relationshipsDefine regulatory strategy with supervisionFollow scientific arguments, identify regulatory scientific data needs and with supervision solve regulatory issuesPreferred
QualificationsBachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, engineering, scientific affairs, operations, or related area.Advanced level degreeExperience with EU and other international medical device / drugs / pharma regulations and submissions.Experience with design controls in medical devices, IVDR, Pharma industriesProficient with Excel and PowerPoint and presenting information to leadershipPrevious experience working in a highly matrixed and geographically diverse business environmentStrong verbal and written communications with ability to effectively communicate at multiple levels in the organization.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. Connect with us at
www.abbott.com
, on Facebook at
www.facebook.com/Abbott
and on Twitter @AbbottNews and @AbbottGlobal.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:
ADC Diabetes Care
LOCATION:
United States > Alameda : 2901 Harbor Bay Parkway
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 5 % of the Time
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)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