A Regulatory Affairs Specialist maintains specialized knowledge of state and federal government regulations that affect an employer. Interprets regulations and implements procedures that bring an employer into compliance with regulations; may audit internal compliance with regulations.
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
