Abbott
Medical Events Specialist I
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) 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 OpportunityResponsible for timely review, documentation and filing of Medical Device Reports to the FDA (US), Medical Problem Reports to Health Canada, Medical Incident Reports to the EU/EFTA including France, and Medical Device Incident reports to the rest of world for the division's products. Accountable for meeting the compliance requirements for Medical Device Reporting regulations including (803). This includes but is not limited to: the efficient and timely review, documentation and filing of potentially reportable events.What You’ll Work OnReview medical complaints and potentially reportable events, gather required additional information to determine the reportability of the complaint in accordance with regulations.
Document filing decision rationale in the Complaint Handling System.
Ensure timely submission of reportable medical events and malfunctions to regulatory authorities in accordance with local and international regulations.
Monitor the status of submitted vigilance reports and ensure follow – up actions are completed in timely manner.
Collaborate with internal teams such as customer service, Complaint evaluation group and complaint investigation team to gather necessary information for vigilance reports.
Provide feedback and recommend solutions within the Quality team to promote accurate documentation of the complaint case.
Assist in maintaining the Malfunction Reportability Assessment Matrix (MRAM), including updates to the Reportable Confirmed Malfunction List (RCML).
Perform verification of MDRs/Viglance reports, including support of data complied for metrics, risk evaluations and various other activities.
Stay updated on regulatory requirements, internal Quality System procedures and guidelines related to medical device vigilance reporting.
Adapt processes and documentation to align with updated regulations.
Interface with management and other functional areas to ensure that Potential Reportable Events (PREs) are obtained in a timely and consistent basis.
Required QualificationsBachelors Degree in related field or an equivalent combination of education and work experience
Minimum of 1 year of experience in Regulatory and 1 yr of experience with Medical Events reporting
Preferred QualificationsAbility to communicate at all levels with clarity and precision both written and verbally.
Excellent problem-solving and critical-thinking skills.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Multitasks, prioritizes and meets deadlines in timely manner.
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 and @AbbottGlobal.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.JOB FAMILY:
Regulatory Operations
DIVISION:
ADC Diabetes Care
LOCATION:
United States > Alameda : 1360-1380 South Loop Road
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
No
MEDICAL SURVEILLANCE:
Not Applicable
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
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) 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 OpportunityResponsible for timely review, documentation and filing of Medical Device Reports to the FDA (US), Medical Problem Reports to Health Canada, Medical Incident Reports to the EU/EFTA including France, and Medical Device Incident reports to the rest of world for the division's products. Accountable for meeting the compliance requirements for Medical Device Reporting regulations including (803). This includes but is not limited to: the efficient and timely review, documentation and filing of potentially reportable events.What You’ll Work OnReview medical complaints and potentially reportable events, gather required additional information to determine the reportability of the complaint in accordance with regulations.
Document filing decision rationale in the Complaint Handling System.
Ensure timely submission of reportable medical events and malfunctions to regulatory authorities in accordance with local and international regulations.
Monitor the status of submitted vigilance reports and ensure follow – up actions are completed in timely manner.
Collaborate with internal teams such as customer service, Complaint evaluation group and complaint investigation team to gather necessary information for vigilance reports.
Provide feedback and recommend solutions within the Quality team to promote accurate documentation of the complaint case.
Assist in maintaining the Malfunction Reportability Assessment Matrix (MRAM), including updates to the Reportable Confirmed Malfunction List (RCML).
Perform verification of MDRs/Viglance reports, including support of data complied for metrics, risk evaluations and various other activities.
Stay updated on regulatory requirements, internal Quality System procedures and guidelines related to medical device vigilance reporting.
Adapt processes and documentation to align with updated regulations.
Interface with management and other functional areas to ensure that Potential Reportable Events (PREs) are obtained in a timely and consistent basis.
Required QualificationsBachelors Degree in related field or an equivalent combination of education and work experience
Minimum of 1 year of experience in Regulatory and 1 yr of experience with Medical Events reporting
Preferred QualificationsAbility to communicate at all levels with clarity and precision both written and verbally.
Excellent problem-solving and critical-thinking skills.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Multitasks, prioritizes and meets deadlines in timely manner.
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 and @AbbottGlobal.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.JOB FAMILY:
Regulatory Operations
DIVISION:
ADC Diabetes Care
LOCATION:
United States > Alameda : 1360-1380 South Loop Road
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
No
MEDICAL SURVEILLANCE:
Not Applicable
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