Regulatory Affairs Manager – Valencia & Burbank, CA
Kelly® Science & Clinical is seeking a Regulatory Affairs Manager for a full-time, onsite position at a biotech company operating in both Valencia and Burbank, CA. If you have expertise in regulatory compliance, quality management systems, and supplier auditing, trust The Experts at Hiring Experts to connect you with your next career opportunity.
Location: On-site in Valencia & Burbank, CA
Pay rate: $100,000 - $140,000 annually DOE
Schedule: Standard PST business hours Monday - Friday
Overview
The Regulatory Affairs Manager works under the guidance of the Director of Quality Operations to ensure regulatory compliance and maintain the company’s Quality System. This role oversees product registrations, regulatory submissions, audits, and quality documentation while also serving as a back-up to the Director of Quality Operations.
Responsibilities
- Ensure compliance with ISO 9001, MDSAP ISO 13485, FDA 21 CFR 820, CE Mark, NRC, DOT, BIS, and other regulatory standards.
- Act as the Calibration Laboratory Management Representative and oversee quality system licensing and registrations.
- Conduct formal audits, issue Corrective and Preventive Actions (CAPAs), and close CAPARs with thorough evaluations.
- Perform regulatory reviews for licensing, registrations, and export compliance.
- Maintain sealed source and device registries, including submissions, amendments, and transfers.
- Approve capsule/package test reports, technical files, and certificates.
- Conduct internal and supplier audits, maintain audit reports, and track supplier qualifications.
- Oversee the Customer Complaints & Returns program, ensuring accurate evaluations and reporting.
- Support the company-wide training program, conducting regulatory seminars and new employee training.
- Assist in document control and final approval of controlled procedures, revisions, and engineering documents.
- Lead hiring, employee development, and performance management within the regulatory team.
Qualifications
- Education: Bachelor’s Degree in Science or related field.
- Experience:
- Minimum 5 years in regulatory affairs, quality assurance, or compliance.
- Expertise in medical device, biotech, or pharmaceutical regulatory systems.
- Skills:
- Strong knowledge of FDA, ISO 13485, CE Mark, and global medical device regulations.
- Experience conducting internal audits and regulatory submissions.
- Excellent organizational, leadership, and training skills.
- Ability to manage multiple compliance programs and regulatory frameworks.
- Proficiency in Microsoft Excel, Word, and ERP/MRP software.
What happens next?
If your background aligns, you’ll move to the next step in the hiring process. Even if this position isn’t the perfect fit, our team of expert Science & Clinical recruiters will keep your profile on hand for future opportunities.
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