Regulatory Affairs Specialist

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PlebC Innovations is a pioneering deep-tech healthcare company developing advanced robotic ultrasound solutions for remote and underserved communities. FYND Talent Solutions is excited to bring you this opportunity to join their mission-driven team.

Key Responsibilities

• Maintain DHF, DMR, Technical Files, Risk Management Files, and related regulatory documentation
• Ensure compliance with ISO 13485, ISO 14971, IEC 60601, IEC 62304, IEC 62366, MDR, CDSCO, and FDA 21 CFR Part 820
• Collaborate with cross-functional teams to support RTM, V&V activities, SOPs, and technical documentation
• Participate in audits, design reviews, and change control activities
• Support the development and implementation of regulatory pathways and documentation systems

Preferred Skills

• Experience in medical device regulatory affairs
• Knowledge of ultrasound, robotic, or healthcare devices
• Familiarity with design controls and regulatory submissions
• Understanding of cybersecurity and software validation requirements
• Experience with ISO audits and compliance reviews

Qualifications

• Bachelor’s / Master’s degree in Biomedical, Electronics, Mechanical, Mechatronics, or related engineering disciplines
• Strong understanding of QMS, risk management, and technical documentation
• Excellent communication, analytical, and organizational skills

Why Join?

• Work on cutting-edge healthcare technology
• Contribute to meaningful innovations in remote diagnostics
• Be part of a fast-growing, mission-driven organization
• Gain exposure to global medical device regulatory practices

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