Abbott Laboratories
Regulatory Affairs Senior Manager - Vascular (on-site)
Abbott Laboratories, Santa Clara, California, us, 95053
Regulatory Affairs Senior Manager - Vascular (on-site)
ApplyLocation:
United States - California - Santa ClaraTime Type:
Full timePosted On:
Posted 30+ Days AgoJob Requisition ID:
31087490Abbott 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 ofFree 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 degreeA 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 FortuneA 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 scientistsAbbott Vascular provides innovative, minimally invasive and cost-effective products for the treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices, and peripheral stents.This
Regulatory Affairs Senior Manager
position is an onsite opportunity working out of our Santa Clara, CA location in the Abbott Vascular Division. The candidate will combine knowledge of scientific, regulatory, and business issues to enable products, including combination products, that are developed, manufactured, or distributed to meet required legislation. This new team member has department/group/site level influence and is generally recognized as an expert resource and mentor within the department.WHAT YOU’LL DO
Provide regulatory input to product lifecycle planning. Provide strategic input and technical guidance on regulatory requirements to development teamsPrepare robust regulatory applications (FDA and international regulatory agencies) to achieve departmental and organizational objectivesAssist in the development of multi-country regulatory strategy and update strategy based upon regulatory changesSupport pre and post-approval clinical strategy and submission activitiesAnticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teamsAssess the acceptability of development, quality, preclinical, and clinical documentation for submission filing. Compile, prepare, review, and submit regulatory submissions to authoritiesNegotiate and interact with regulatory authorities during the development and review process to ensure submission approvalEnsure compliance with US and global product post-marketing approval requirementsEvaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing strategiesExecute and manage technical and scientific regulatory activities. Must function independently as a decision-maker on regulatory issues and must assure that deadlines are metEffectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies. Properly interpret and apply regulatory requirements.Interface with a variety of management levels on significant matters, often requiring the coordination of activity across organizational unitsProvide leadership and guidance towards achieving department objectives and act as a mentor to less-experienced staffMay supervise exempt or non-exempt employeesMay lead a cross-functional or cross-divisional project teamResponsible for compliance with applicable Corporate and Divisional Policies and proceduresRequired Qualifications
Bachelor's Degree in a related field OR an equivalent combination of education and work experienceMinimum 9 years related experience.Provides direction and monitors progress of exempt specialists and/or supervisory staff toward departmental goals.Monitors costs of projects and of human and material resources within a department or unit.Monitors company-wide indicators such as market share and profitability.Monitors external environment in area of technical or professional responsibility.Develops and/or identifies new work processes and the improved utilization of human and material resources within the assigned or related functions or groups.Facilitates others' participation in the continuous improvement program.Investigates and solves problems that impact work processes and personnel within or across units or departments.Develops and communicates a vision for the organizational unit assigned.Preferred Qualifications
Bachelor's degree in science, math, engineering, or medical fields.Master’s or Ph.D. in a technical areaPrevious experience with PMA / IDE and international submissionsExperience with combination product and/or Class III medical devicesExperience with IDE trial strategy and post-market clinical activitiesAbility to define regulatory strategy. Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.Experience with post-approval manufacturing and design changesAbility to effectively communicate verbally and in writing, prepare, and negotiate both internally and externally with various regulatory agencies.Ability to work effectively on cross-functional teamsStrong attention to detailExperience with organizing and tracking complex information. Able to juggle multiple and competing prioritiesExperience with exercising judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results. Has broad knowledge of various technical alternatives and their potential impact on the businessUses in-depth knowledge of business functions and cross-group dependencies/relationshipsApply 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:
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.The base pay for this position is:
$125,700.00 – $251,500.00In specific locations, the pay range may vary from the range posted.JOB FAMILY:
Regulatory OperationsDIVISION:
AVD VascularLOCATION:
United States > Santa Clara : Building B - SCWORK SHIFT:
StandardTRAVEL:
Yes, 10 % of the TimeMEDICAL SURVEILLANCE:
NoSIGNIFICANT 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)
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ApplyLocation:
United States - California - Santa ClaraTime Type:
Full timePosted On:
Posted 30+ Days AgoJob Requisition ID:
31087490Abbott 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 ofFree 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 degreeA 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 FortuneA 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 scientistsAbbott Vascular provides innovative, minimally invasive and cost-effective products for the treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices, and peripheral stents.This
Regulatory Affairs Senior Manager
position is an onsite opportunity working out of our Santa Clara, CA location in the Abbott Vascular Division. The candidate will combine knowledge of scientific, regulatory, and business issues to enable products, including combination products, that are developed, manufactured, or distributed to meet required legislation. This new team member has department/group/site level influence and is generally recognized as an expert resource and mentor within the department.WHAT YOU’LL DO
Provide regulatory input to product lifecycle planning. Provide strategic input and technical guidance on regulatory requirements to development teamsPrepare robust regulatory applications (FDA and international regulatory agencies) to achieve departmental and organizational objectivesAssist in the development of multi-country regulatory strategy and update strategy based upon regulatory changesSupport pre and post-approval clinical strategy and submission activitiesAnticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teamsAssess the acceptability of development, quality, preclinical, and clinical documentation for submission filing. Compile, prepare, review, and submit regulatory submissions to authoritiesNegotiate and interact with regulatory authorities during the development and review process to ensure submission approvalEnsure compliance with US and global product post-marketing approval requirementsEvaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing strategiesExecute and manage technical and scientific regulatory activities. Must function independently as a decision-maker on regulatory issues and must assure that deadlines are metEffectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies. Properly interpret and apply regulatory requirements.Interface with a variety of management levels on significant matters, often requiring the coordination of activity across organizational unitsProvide leadership and guidance towards achieving department objectives and act as a mentor to less-experienced staffMay supervise exempt or non-exempt employeesMay lead a cross-functional or cross-divisional project teamResponsible for compliance with applicable Corporate and Divisional Policies and proceduresRequired Qualifications
Bachelor's Degree in a related field OR an equivalent combination of education and work experienceMinimum 9 years related experience.Provides direction and monitors progress of exempt specialists and/or supervisory staff toward departmental goals.Monitors costs of projects and of human and material resources within a department or unit.Monitors company-wide indicators such as market share and profitability.Monitors external environment in area of technical or professional responsibility.Develops and/or identifies new work processes and the improved utilization of human and material resources within the assigned or related functions or groups.Facilitates others' participation in the continuous improvement program.Investigates and solves problems that impact work processes and personnel within or across units or departments.Develops and communicates a vision for the organizational unit assigned.Preferred Qualifications
Bachelor's degree in science, math, engineering, or medical fields.Master’s or Ph.D. in a technical areaPrevious experience with PMA / IDE and international submissionsExperience with combination product and/or Class III medical devicesExperience with IDE trial strategy and post-market clinical activitiesAbility to define regulatory strategy. Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.Experience with post-approval manufacturing and design changesAbility to effectively communicate verbally and in writing, prepare, and negotiate both internally and externally with various regulatory agencies.Ability to work effectively on cross-functional teamsStrong attention to detailExperience with organizing and tracking complex information. Able to juggle multiple and competing prioritiesExperience with exercising judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results. Has broad knowledge of various technical alternatives and their potential impact on the businessUses in-depth knowledge of business functions and cross-group dependencies/relationshipsApply 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:
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.The base pay for this position is:
$125,700.00 – $251,500.00In specific locations, the pay range may vary from the range posted.JOB FAMILY:
Regulatory OperationsDIVISION:
AVD VascularLOCATION:
United States > Santa Clara : Building B - SCWORK SHIFT:
StandardTRAVEL:
Yes, 10 % of the TimeMEDICAL SURVEILLANCE:
NoSIGNIFICANT 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)
#J-18808-Ljbffr