Job Description

Job Description

Job Description

Regulatory Affairs Specialist (Temporary - minimum 6 months to potentially 1 year)

Pay Rate: $40-$50/hour DOE
Location: Valencia, CA and occasionally in Burbank, CA
Minimum Education: B.S. in Science
Minimum Experience: 5 years of experience in medical devices. Experience in pharmaceutical regulatory requirements is desired but not required. Candidates must be familiar with ISO: 13485.

Summary: This position assists the Director of Quality Operations (DQO) in maintaining an effective Quality Operations and Regulatory Program, which consistently delivers high quality EZIP products on time. Handles regulatory submissions, CAPAs, customer complaints, conducts regulatory reviews and participates in audits to verify that appropriate current procedures and applicable regulations are followed, and keeps the DQO fully informed on status of QA, QC, DC, and RA activities. This person will also be back-up to Radioassay.

Qualifications:
Knowledge of FDA medical devices and/or pharmaceutical (drug) registrations.
Familiar with regulatory submissions and performing audits.
Experienced in QA systems: FDA, ISO 13485, MDR/MDD, MDSAP.
Self-starter, strong communicator, and has good time and project-management.
Detail oriented, organized, and has excellent verbal and written communication skills.
Proficient in Microsoft Word, Excel, and ERP/MRP software.
Must be onsite in the office 5 days a week.
Must be available to work overtime if necessary.

EEO/AA Employer/Vet/Disabled.

The Know Your Rights poster is available here:
-06/22-088_EEOC_KnowYourRights6.12.pdf

The pay transparency policy is available here:
- transp_%20English_formattedESQA508c.pdf

For temporary assignments lasting 13 weeks or longer, the Company is pleased to offer major medical, dental, vision, 401k and any statutory sick pay where required.

We are committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation for any part of the employment process, please contact your staffing representative who will reach out to our HR team.

AppleOne participates in the E-Verify program in certain locations as required by law. Learn more about the E-Verify program.
verify.uscis.gov/web/media/resourcesContents/E - Verify_Participation_Poster_ES.pdf

We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

#1091

Company Description

This company offers growth and a great group of people to work with.

Job Tags

Temporary work,

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