Quality & Regulatory Specialist (ISO 9001 / ISO 13485)

Quality & Regulatory Specialist (ISO 9001 / ISO 13485)

Position Summary

We are seeking a detail-oriented Quality & Regulatory Specialist with hands-on experience in ISO 9001 and ISO 13485 within a regulated environment. This role supports the maintenance and continuous improvement of the Quality Management System (QMS) to ensure compliance with U.S. and international regulatory standards.

This position is ideal for someone who is highly organized, process-driven, and experienced in quality systems, with the ability to support cross-functional teams and assist with production, quality, and regulatory initiatives.

Key Responsibilities

• Support and assist managers with maintaining and improving the Quality Management System (QMS) in compliance with ISO 9001 and ISO 13485
• Assist managers with ensuring adherence to regulatory requirements including FDA (21 CFR Part 820) and IVDR (EU 2017/746)
• Assist managers with internal and external audits, including preparation, coordination, and follow-up actions
• Support CAPA activities, including tracking, documentation, and follow-up to ensure timely resolution
• Maintain document control processes, including SOP creation, revisions, and change management
• Assist managers with regulatory documentation, technical files, and inspection readiness
• Support monitoring of production processes, product quality, and risk management activities
• Coordinate calibration, maintenance, and quality control processes to support proper equipment and system functionality
• Assist with reviewing customer feedback, complaints, and non-conforming products; support trend tracking and corrective actions
• Support supplier quality activities, including vendor documentation, qualification support, and audit coordination
• Track quality metrics, quality objectives, and continuous improvement initiatives
• Maintain traceability records, inventory quality documentation, and QMS files
• Coordinate and assist with delivery of quality and regulatory training; maintain employee training matrix
• Partner with operations, engineering, production, and regulatory teams to support alignment and compliance
• Assist managers with preparing for management reviews and compiling quality data and reports

Qualifications

• Bachelor’s degree in a related field or equivalent experience
• 2+ years of experience in quality management or regulatory compliance
• Working knowledge of ISO 9001 and ISO 13485 (required)
• Experience with IVDR or IVD regulatory environments (preferred, not required)
• Experience in a regulated environment (medical device, manufacturing, or IVD preferred)
• Familiarity with FDA regulations (21 CFR Part 820) is a plus
• Experience with CAPA, audits, document control, and QMS systems
• Proficiency in Microsoft Office (Excel, Word, Outlook) required
• Strong attention to detail, organization, and problem-solving skills
• Ability to manage multiple priorities in a fast-paced environment
• Strong communication skills and ability to work cross-functionally

Preferred Qualifications

• Experience in medical device or IVD manufacturing
• Exposure to EU regulatory submissions and technical documentation
• Experience with electronic QMS systems
• Familiarity with risk management tools (FMEA, root cause analysis)

What Success Looks Like

• QMS documentation and processes are consistently maintained and audit-ready
• CAPA tracking, audits, and documentation are completed accurately and on time
• Strong support provided to managers and cross-functional teams
• Continuous improvements that enhance efficiency, compliance, and product quality

Hiring Timeline

We are actively interviewing and looking to make a hire within the next 1–2 weeks. Qualified candidates are encouraged to apply immediately.