Regulatory Affairs Manager

By | June 8, 2025

Regulatory Affairs Manager

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Job ID: 9842821

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Valencia, CA, US

Scientific

Bachelors Degree

Full Time, Direct Hire

$100,000 - $140,000/year DOE

Manager (Manager/Supervisor)

On-site

Biotechnology/Pharmaceuticals

First Shift (Day)

Valencia, CA, US

$100,000 - $140,000/year DOE

Manager (Manager/Supervisor)

Full Time, Direct Hire

Biotechnology/Pharmaceuticals

On-site

Scientific

Bachelors Degree

First Shift (Day)

Apply Now Applied

Job details

  • Regulatory Affairs Manager 

  • Location: Onsite in Valencia & Burbank, CA

  • Salary: $100,000–$140,000/year (DOE)

  • Industry: Medical Device / Life Sciences

Kelly® Science & Clinical is hiring a Regulatory Affairs Manager for a leading client. In this role, you’ll ensure compliance with FDA, ISO, and international regulations and submissions while managing regulatory programs across two facilities.

Key Responsibilities:

  • Oversee regulatory submissions (FDA, EU MDR, international).


  • Maintain product registrations, certifications, and export licenses.


  • Lead internal/supplier audits and CAPAs; train auditors.


  • Manage document control, sealed source/device registries, and complaint programs.


  • Prepare/approve procedures, ECOs, and testing documentation.


  • Support quality training and system improvements.


  • Supervise and develop Regulatory Affairs staff.


  • Travel between Valencia, Burbank, and supplier sites.

Qualifications:

  • Bachelor’s degree in a scientific discipline.


  • Minimum 5 years’ management experience in a similar role.


  • Proven experience with 5 years or more of FDA submissions and international regulatory compliance.


  • Lead Auditor certification preferred.


  • Strong communication, organizational, and ERP system skills.

What happens next:

If your qualifications align with the requirements of this role, we invite you to apply and take the next step in your career journey. Rest assured, even if this opportunity isn’t the perfect match, your profile will remain within our network, ensuring you’re connected to a wealth of future opportunities in the field of science and clinical research.

Join us in making a difference by applying today!
Thank you,
Kelly Team
P1#9842821

9842821

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Why Kelly® Science & Clinical?

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