Abbott
Sr. Manager Regulatory Affairs
Abbott, Santa Clara, California, us, 95053
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:
About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. 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. Free medical coverage for employees* via the Health Investment Plan (HIP) PPO 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 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. The Opportunity This position works out in our facilities of Santa Clara CA in the Diagnostics Division. We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. What You’ll Work On We are recruiting for a SENIOR MANAGER REGULATORY AFFAIRS to join the Regulatory team at the Santa Clara, CA location. In this role, you be responsible for coordinating, planning, preparation, assembly, and review of regulatory strategies and submissions to the FDA, Notified Bodies, and other worldwide regulatory agencies as well as daily regulatory operations. What you will do: Recruits, coaches, and develops organizational talent. Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. Provides direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments. May supervise non-exempt employees. Keeps the organization's vision and values at the forefront of decision making and action. Demonstrates effective change leadership. Builds strategic partnerships to further departmental and organizational objectives. Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills. Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc.). Makes decisions regarding work processes or operational plans and schedules in order to achieve department objectives. Develop regulatory strategies, clearance/approval schedules, and submission standards to achieve departmental and organizational objectives. Assess proposed regulations and communicate new requirements to the organization. Conducts and supports necessary regulatory activities required for product market entry of instrument hardware/software and reagents. Conduct reviews of product design and manufacturing changes for compliance with applicable regulations. Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team. Provides guidance and expertise. 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. Interface directly with FDA, Notified Body, and other regulatory agencies. Work with cross-functional team to support product release process. Review protocols and reports to support regulatory submissions. Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Comply with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Performs other related duties and responsibilities, on occasion, as assigned Required Qualifications Bachelor’s Degree in life sciences, engineering, other technical discipline, or Regulatory Affairs Minimum of 9 years of related work experience Provides direction and monitors progress of exempt specialists and/or supervisory staff toward departmental goals. Facilitates others' participation in continuous improvement programs. 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. Technical or Medical Writing experience Class I, II, and/or III medical device experience Monitors relevant US/international regulatory requirements for medical devices including Quality Systems standards and clinical investigations. Proficient with MS Office Suite (Word, Excel, PowerPoint, Outlook) Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Preferred Qualification Master’s Degree or Doctorate Degree Minimum of 9 years of Regulatory affairs job experience in the medical device industry Experience with pre-submissions, 510(k) submissions, Instrument/Software Submission, Design Planning, and On-Market Changes Experience working in a broader
enterprise/cross-division
business unit model * 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.com Follow 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 and @AbbottGlobal. The base pay for this position is $125,700.00 – $251,500.00
In specific locations, the pay range may vary from the range posted. JOB FAMILY:
Regulatory Operations
DIVISION:
CRLB Core Lab
LOCATION:
United States > Santa Clara : 4551 Great America Parkway
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 10 % 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 (greater or equal to 50% of the workday)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
About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. 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. Free medical coverage for employees* via the Health Investment Plan (HIP) PPO 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 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. The Opportunity This position works out in our facilities of Santa Clara CA in the Diagnostics Division. We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. What You’ll Work On We are recruiting for a SENIOR MANAGER REGULATORY AFFAIRS to join the Regulatory team at the Santa Clara, CA location. In this role, you be responsible for coordinating, planning, preparation, assembly, and review of regulatory strategies and submissions to the FDA, Notified Bodies, and other worldwide regulatory agencies as well as daily regulatory operations. What you will do: Recruits, coaches, and develops organizational talent. Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. Provides direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments. May supervise non-exempt employees. Keeps the organization's vision and values at the forefront of decision making and action. Demonstrates effective change leadership. Builds strategic partnerships to further departmental and organizational objectives. Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills. Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc.). Makes decisions regarding work processes or operational plans and schedules in order to achieve department objectives. Develop regulatory strategies, clearance/approval schedules, and submission standards to achieve departmental and organizational objectives. Assess proposed regulations and communicate new requirements to the organization. Conducts and supports necessary regulatory activities required for product market entry of instrument hardware/software and reagents. Conduct reviews of product design and manufacturing changes for compliance with applicable regulations. Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team. Provides guidance and expertise. 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. Interface directly with FDA, Notified Body, and other regulatory agencies. Work with cross-functional team to support product release process. Review protocols and reports to support regulatory submissions. Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Comply with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Performs other related duties and responsibilities, on occasion, as assigned Required Qualifications Bachelor’s Degree in life sciences, engineering, other technical discipline, or Regulatory Affairs Minimum of 9 years of related work experience Provides direction and monitors progress of exempt specialists and/or supervisory staff toward departmental goals. Facilitates others' participation in continuous improvement programs. 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. Technical or Medical Writing experience Class I, II, and/or III medical device experience Monitors relevant US/international regulatory requirements for medical devices including Quality Systems standards and clinical investigations. Proficient with MS Office Suite (Word, Excel, PowerPoint, Outlook) Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Preferred Qualification Master’s Degree or Doctorate Degree Minimum of 9 years of Regulatory affairs job experience in the medical device industry Experience with pre-submissions, 510(k) submissions, Instrument/Software Submission, Design Planning, and On-Market Changes Experience working in a broader
enterprise/cross-division
business unit model * 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.com Follow 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 and @AbbottGlobal. The base pay for this position is $125,700.00 – $251,500.00
In specific locations, the pay range may vary from the range posted. JOB FAMILY:
Regulatory Operations
DIVISION:
CRLB Core Lab
LOCATION:
United States > Santa Clara : 4551 Great America Parkway
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 10 % 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 (greater or equal to 50% of the workday)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