Regulatory Affairs Specialist I

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.

• 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 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

We are recruiting for a Regulatory Affairs Specialist I to join our team on-site in Sylmar, CA or 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 influence generally at the middle management level. The individual may assist in the registration of products by preparing and submitting documentation needed for US and international registration assessments.

What You’ll Work 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, AU and CA

• TUV Appendix ABC Information Tracking and updates – EU product information including key processes, facilities and 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 performing back room support

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

• General support as 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 to leverage and/or engage others to accomplish projects.

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

• Multitasks, prioritizes and meets deadlines in timely manner.

• 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 and locating information.