2018-07-08

Regulatory Compliance Manager
Job Opportunity at MEIRxRS / Med Exec Intl

Posted on Jul 8

https://meirxrs.com    818-247-1368

Location: Irvine, CA
Job Type: Full Time
Job ID: W4159296

Client is seeking a Regulatory Affairs Compliance Manager to ensure regulatory compliance is implemented and followed at this high-volume contract manufacturer.

Requirements
Manufacturing experience should include FDA-regulated products such as pharmaceuticals, over the counter drugs, or dietary supplements.
Bachelor Degree

Duties
•    Manage coordinate and prioritize the daily activity of the department and related staff
•    Interact with various departments as needed on regulatory compliance issues 
•    Direct, plan, delegate and manage departmental budget and staff 
•    Manage, maintain and support effective implementation of Regulatory Affairs
•    Ensure compliance relating to product, labeling registration and licensing
•    Oversee, conduct, and review investigations relating to customer complaints, deviations, and product variances, or failure investigations
•    Oversee and ensure SOPs and company policies are in compliance with regulatory requirements and GMPs
•    Provide support in both internal and external audits to ensure regulatory compliance
•    Obtain licenses and certifications from State and Federal agencies, third party Certification bodies, other customer third party inspections and foreign registrations 
•    Oversee and schedule internal audit and take lead in the resolution of non-compliance
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