Top 1 Regulatory affairs specialist Jobs in Oceanside Ca

Quality Assurance & Regulatory Affairs Specialist
Oranoxis Inc. —San Diego, CA
- $50,000 - $90,000 a year
- Full-time
- Mid-level
- Bachelor's degree
- US work authorization
- Health insurance
- Paid time off
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Quality Assurance & Regulatory Affairs Specialist

Oranoxis Inc.
San Diego, CA

Quick Apply

Job Details

Full-time
$50,000 - $90,000 a year
8 days ago

Benefits

Health insurance
Paid time off
Flexible schedule

Qualifications

Content creation for technical audiences
Laboratory equipment performance testing and validation
Interpersonal skills
Laboratory instrument validation
Technical writing experience within manufacturing
Laboratory equipment calibration
Manufacturing facility experience
Bachelor's degree
Attention to detail
Organizational skills
Quality audits
Cross-functional communication
Office record organization

Full Job Description

Oranoxis Inc. was founded by a pioneer in the lateral flow oral fluid drug testing industry. Over the last decade Oranoxis has found a strong customer basis, but is now seeking greater opportunities in growth.

Our flagship products are made in the USA and sold in the EU, AUS/NZ, North America, and South East Asia through local distributors. Oranoxis meets the challenge of achieving local regulatory requirements and presents a wide variety of product options for oral fluid drug testing.

Job Responsibilities:
We are seeking a detail-oriented Quality Assurance & Regulatory Affairs Specialist to lead company-wide QA initiatives and drive regulatory alignment with ISO 13485 and KGMP (Korean Good Manufacturing Practice) standards. This role will initially focus on establishing and maintaining rigorous internal QA documentation for laboratory and manufacturing equipment, before expanding into broader regulatory and quality system responsibilities as the department grows.

This is an excellent opportunity for a quality-minded professional with hands-on lab or biotech experience to build and shape foundational QA infrastructure at a growing organization.

Equipment Qualification & Documentation (Primary Focus)

Develop, update, and maintain QA records and documentation for laboratory and automation equipment, including but not limited to ovens, centrifuges, pipettes, incubators, and automated liquid handling systems
Execute and document equipment qualification protocols — Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
Maintain calibration schedules, preventive maintenance logs, and equipment validation records
Ensure all equipment documentation is audit-ready and traceable in accordance with ISO 13485 and KGMP requirements
Identify and correct documentation gaps in existing equipment files

Quality Management System (QMS) & Regulatory Alignment

Support and help maintain company-wide QMS processes in alignment with ISO 13485 requirements
Assist in preparing for and supporting KGMP compliance audits and inspections
Collaborate cross-functionally with lab, manufacturing, and operations teams to ensure consistent QA practices
Contribute to the development of SOPs, work instructions, and quality records
Support internal audits and assist in CAPA (Corrective and Preventive Action) documentation and tracking
Assist with change control processes related to equipment and documentation updates

Required Qualifications

Bachelor's degree in a relevant scientific, engineering, or quality field (or equivalent practical experience)
Prior experience in a laboratory, biotech, medical device, or pharmaceutical environment
Working knowledge of equipment qualification processes (IQ/OQ/PQ) and calibration/maintenance documentation
Strong understanding of documentation practices and quality record-keeping (GDP — Good Documentation Practices)
Excellent organizational skills and high attention to detail
Strong written communication skills for technical documentation
Ability to work both independently and cross-functionally with lab and operations teams

Preferred Qualifications

Direct experience with ISO 13485 quality management systems
Familiarity with KGMP or other regional GMP frameworks (FDA QSR, EU MDR, etc.)
Experience supporting internal or external quality audits
Experience with electronic QMS (eQMS) platforms
Background in medical device, diagnostics, or life sciences manufacturing

Job Type: Full-time

Pay: $50,000.00 - $90,000.00 per year

Benefits:

Flexible schedule
Health insurance
Paid time off

Education:

Bachelor's (Preferred)

Experience:

Organizational Compliance Occupations: 1 year (Preferred)
FDA, Euro CE IVDR, or ISO:13845: 1 year (Preferred)

Work Location: In person

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