Job Description

🚀 AUGUST HIRING ALERT!
📌 Role: Assistant Manager – Regulatory & Quality

We’re looking for a motivated, dynamic, and experienced professional to join our team as an Assistant Manager – Regulatory & Quality. In this role, you’ll support senior management and drive excellence in regulatory compliance, quality systems, and project execution across multi-disciplinary teams.

🌟 Key Responsibilities:

1. Provide leadership and partner with Senior Manager to deliver organizational success.
2. Develop and execute project delivery plans, ensuring technical accuracy, scope, and timelines.
3. Lead, mentor, and coordinate multi-functional teams across all project phases.
4. Oversee regulatory submissions (510(k), ISO 13485, ISO 9001, QSR, CE Marking, global approvals).
5. Act as a subject matter expert in QMS—support audits, CAPAs, and continuous improvement initiatives.
6. Ensure compliance with QMS policies, PM processes, and international regulations.
7. Serve as the central contact for cross-functional technical teams and clients.
8. Leverage AI tools to optimize project deliverables and documentation.
9. Provide training and support development of regulatory & quality teams.

🎯 Desired Skills & Background

– Bachelor’s degree in Biomedical Engineering or related field.
– 3+ years of hands-on experience managing projects for US FDA, EU MDR/IVDR, and TGA submissions.
– Strong experience in regulatory writing for Medical Devices/IVDs.
Excellent communication skills (written & verbal).
– Ability to quickly learn and understand new medical device technologies (including PEMS & SaMD).
– Strong analytical, leadership, and client interaction skills.
📩 Interested candidates matching the above profile are encouraged to share their updated CV with us at lisa@elexes.com
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Join us and make an impact in shaping regulatory excellence and quality standards! 🌍✨