*Regulatory Affairs Specialist* 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.
location: Valencia, California
job type: Contract
salary: $38 - 50 per hour
work hours: 7 to 3
education: Bachelors
responsibilities:
* Deliver high quality products on time
* Handle regulatory submissions, CAPAs, customer complaints
* Conduct regulatory reviews and participate in audits to verify that proper procedures and applicable regulations are followed
* Keep DQO informed on status of QA, QC, DC, and RA activities.
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.
skills: CMC, GCP (Good Clinical Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
