Regulatory Affairs Specialist I
: Job Details :

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.

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'llalso have access to:

· Career development with an international company where you can grow the career you dream of.

· Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year

· An excellent retirement savings plan with high employer contribution · Tuition reimbursement, the Freedom 2 Save student debt program andFreeUeducation benefit - an affordable and convenient path to getting a bachelor's degree.

· A company recognized asa great placeto 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

We are recruiting for a Regulatory Affairs Specialist I to join our team on-site inSylmar, CAor Scottsdale, AZ. As an individual contributor, the function of a Regulatory Affairs Specialist I is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and exercise influencegenerally atthe middle management level. The individual mayassistin the registration of products by preparing andsubmittingdocumentation needed forUS andinternational registration assessments.

WhatYou'llWork On

• Annual Reports– FDA APRs, ARCs (support), Custom Devices,Ics(support).Tracking of annual FDA PMA payments.

• FDA Establishment Registrations for CRM Sites (3).Includes all FURLS DL maintenance and annual verification.

• Export Documentation– CFG, COE, Notifications

• UDI Support– FDA and EU

• Management of EU and AU Declarations of Conformity (DoCs)

• Submission and Approved Product Tracking and Reporting– US, EU,AUand CA

• TUV Appendix ABC Information Tracking and updates– EU product information including key processes,facilitiesand supplier information

• Certificate Management

• Windchill, SAP and Informatica– key systems

• CRM Regulatory CO capabilities to update documents

• Audit support– providing Regulatory information for CRM related audits and performingback roomsupport

• Product Rationalization– US, EU, CA notifications of discontinuances and shortages, FURLS, GUDID and EUDAMED updates for discontinued products.

• General supportas needed.

• Support key submissions when requested

Required Qualifications–

· Bachelor's Degree or an equivalent combination of education and work experience

• Experience working in a broader enterprise/cross-division business unit model preferred.

• Ability to work in a highly matrixed and geographically diverse business environment.

• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.

• Ability toleverageand/or engage others toaccomplishprojects.

• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

• Multitasks,prioritizesand meets deadlines intimelymanner.

• Strong organizational and follow-up skills, as well as attention to detail.

Preferred Qualifications

· Bachelor'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.)

· Think analytically with good problem-solving skills.

· Strong attention to detail and organization skills.

· Self-driven to perform tasks such as researching regulatory requirements andlocatinginformation.

The base pay for this position is $72,100.00– $114,700.00. In specific locations, the pay range may vary from the range posted.