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Sr. Regulatory Affairs Specialist


This is a Full-time position in Los Angeles, CA posted June 19, 2022.

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 113,000 colleagues serve people in more than 160 countries.About AbbottDiagnostic testing is a compass, providing information that helps in the prevention, diagnosis and treatment of a range of health conditions. Abbotts life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. Were 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 Abbotts diagnostics instruments, providing lab results for millions of people.Our location in Lake Forest, IL or Pomona, CA currently has an opportunity for a Sr. Regulatory Affairs Specialist.This role is responsible for directing and coordinating the implementation of regulatory compliance programs as required by federal, state, and local government agencies. This includes achieving government registration and licensure approval of new products and assuring that current products and manufacturing operations are in compliance with applicable regulations. You will interact with Marketing, Sales Regional Regulatory Affairs staff, regional distributors, governmental regulatory agencies and other third-party accrediting bodies. Remote work may be considered based on candidate experience.WHAT YOULL DOProvides regulatory support for commercial diagnostic products Develops regulatory strategies to achieve clearance/approval internationally (outside United States)Compiles and publishes all material required for submissions, license renewals, and annual registrations Works with governmental regulatory agencies and other third-party accrediting bodies Maintains approvals/licenses/authorizations for existing marketing authorizationsAdds and maintains information contained in the Global Regulatory Information DatabaseProvides recommendations on labeling, for regulatory compliance Develops internal procedures and toolsConducts informational or training sessions for stakeholdersOrganizes and maintains hard copy and electronic department filesKeeps informed of global regulatory informationDemonstrates commitment to the development, implementation and effectiveness of Company Quality Management System per ISO, FDA, and other regulatory agencies.Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.EDUCATION AND EXPERIENCE YOULL BRINGRequiredBachelors degree (BS/BA) in a scientific field3-5 years of experience in a regulated industry Proficient with Microsoft Office, including Word, Excel, PowerPoint and VisioAble to work on multiple tasks as a team member and/or ability to operate as an individual contributorMust be detail-orientated, self-motivated and available for flexible schedulingStrong written and verbal communication, problem solving and motivational skillsRemote may be considered based on candidate experienceMDR/IVDR/technical file experience or 510(k) experiencePreferred3 years of experience in Regulatory Affairs Three plus years in an IVD or medical device manufacturing environment510k submission experienceTechnical file creation and maintenance experienceStrong knowledge of US and Foreign regulationsAble to work on multiple tasks simultaneously as a team member and/or ability to operate as an individual contributorPossess a high degree of accuracy, detail-orientated, self-motivated and available for flexible schedulingRemote work may be considered based on candidate experienceWHAT WE OFFER At Abbott, you can have a good job that can grow into a great career. We offer:Training and career development, with onboarding programs for new employees and tuition assistanceFinancial security through competitive compensation, incentives and retirement plansHealth care and well-being programs including medical, dental, vision, wellness and occupational health programsPaid time off401(k) retirement savings with a generous company matchThe stability of a company with a record of strong financial performance and history of being actively involved in local communitiesLearn more about our benefits that add real value to your life to help you live fully: Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.Job SummaryJob number: 31023563Date posted : 2022-06-08Profession: LegalEmployment type: Full time
Associated topics: laboratory, medical, pathology, sample collection, scientist, services, technician i, technician iv, technician lab, technician laboratory