Regulatory Affairs – Quality Assurance Associate/Specialist

November 12

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RQM+

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Healthcare Insurance • Biotechnology • Artificial Intelligence

RQM+ is a global MedTech service provider that accelerates compliance and market success for medical device and in vitro diagnostics (IVD) companies. Offering comprehensive services throughout the product lifecycle, RQM+ specializes in regulatory and quality consulting, lab services, clinical trials, and reimbursement strategies. With a team of seasoned consultants, many of whom are former FDA and EU regulators, the company provides unmatched expertise in handling complex regulatory environments. Jordi Labs, a subsidiary, enhances the service offering with advanced materials science and chemical characterization capabilities. RQM+ utilizes innovative platforms like Fern. ai to streamline regulatory documentation and expedite market entry for life-saving medical technologies.

501 - 1000 employees

⚕️ Healthcare Insurance

🧬 Biotechnology

🤖 Artificial Intelligence

📋 Description

• Support the execution and documentation of Corrective and Preventive Actions (CAPAs) • Assist in vendor qualification, monitoring, and management activities • Maintain and update quality and regulatory documentation (procedures, work instructions, forms, etc.) • Help prepare regulatory submissions and responses under supervision • Participate in internal audits and support external audit readiness • Track and follow up on quality metrics and improvement initiatives • Collaborate cross-functionally with RA, QA, Operations, and Engineering teams

🎯 Requirements

• Bachelor’s degree in a scientific, engineering, or healthcare-related field OR equivalent experience in regulatory or quality roles within the medical device industry • 1–3 years of experience in RA/QA for medical devices (SaMD experience is a plus but not required) • Familiarity with ISO 13485, FDA 21 CFR Part 820, and other relevant regulatory frameworks • Strong organizational and communication skills • Proficiency with document control systems and Microsoft Office tools

🏖️ Benefits

• Ongoing learning and development • Work-life balance