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Regulatory Affairs Specialist I or II (depending on experience)

Company Name: Abbott (formerly Alere)
Location: Carlsbad, CA
Job Type: Temp to Hire
Contact Name: Khalid Mansoor
Phone: 858-805-2566
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
Salary: Competitive Hourly Rate

Job Description

The Regulatory Affairs Specialist i (II, depending on experience) will work as part of the Regulatory Affairs department with direct responsibility for the preparation of documentation for domestic and international product registrations for new and modified products.

Additionally, he/she will be responsible for reviewing advertising & promotional material and review against the claims in the package insert.

This candidate will participate in core team meetings and will be expected to take ownership of the registration activities, prepare and track documentation packages for country registrations, maintain approvals/licenses/authorizations, research requirements and scientific data, and communicate effectively to direct manager and to key stakeholders. 

The candidate will assist with developing and maintaining current internal procedures and tools.

Job Requirements

Must be able to work from the Carlsbad office.

Bachelor's degree (BS/BA) in any
biological science. Advanced degree
may substitute for work experience

1-3 years of experience in Regulatory Affairs, preferably in an IVD or medical device manufacturing environment. 

Good knowledge of domestic and international regulations of medical devices. 

Must possess a high degree of proficiency, accuracy and attention to detail. Proficient in Microsoft Office, including Word, Excel and Powerpoint.