About the Role

We are seeking a highly skilled Regulatory Affairs Professional to join our team focusing on advanced medical imaging devices, specifically CT scanners and related software. The ideal candidate will have comprehensive experience in regulatory submissions, global medical device regulations, and compliance management for both hardware and software components. This role demands close collaboration with R&D, Quality, and Marketing teams to ensure smooth regulatory pathways and post-market compliance.

Key Responsibilities

• Lead and execute regulatory submissions for CT scanners and associated software across multiple regions, including APAC, ASEAN, EU, and others.
• Ensure compliance with global medical device regulations such as MDR (EU), FDA 21 CFR Part 820 (US), and local country-specific regulations.
• Prepare and maintain technical documentation, risk management files, and regulatory dossiers for software and hardware medical device products.
• Support product lifecycle management, including updates, upgrades, and post-market surveillance activities.
• Interface with notified bodies, regulatory authorities, and certification bodies to facilitate product approvals and audits.
• Provide regulatory guidance in design and development phases to mitigate risks and ensure compliance from early stages.
• Monitor changes in regulatory landscapes and implement compliant processes and product adaptations accordingly.
• Mentor and guide junior regulatory staff and act as a key regulatory contact within cross-functional project teams.

Required Qualifications and Experience

• Bachelor’s or Master’s degree in Life Sciences, Engineering, or a related field. Advanced degrees or certifications in Regulatory Affairs preferred.
• 8 - 10 years of experience in regulatory affairs within the medical device industry, specifically with imaging devices (CT scanners) and medical device software.
• Proven track record in preparing and submitting regulatory dossiers to notified bodies and regulatory agencies.
• Deep understanding of regulatory frameworks and standards for medical devices and medical software worldwide.

Knowledge of Standards and Guidelines (mandatory)

• IEC 60601 series (Medical electrical equipment – essential safety and performance)
• ISO 13485 (Medical devices – Quality management systems)
• ISO 14971 (Application of risk management to medical devices)
• IEC 62304 (Medical device software – Software life cycle processes)
• IEC 62366 (Usability engineering for medical devices)
• ISO 14155 (Clinical investigation of medical devices)
• FDA 21 CFR parts 820, 807, and 814 (if applicable)
• Knowledge of MDR (EU) 2017/745 and IVDR if relevant
• Understanding of cybersecurity standards for medical devices (e.g., IEC 62443) is a plus
• Experience with software validation and verification processes

Desired Skills

• Excellent communication skills in English; additional language skills (e.g., German) are a plus
• Ability to work cross-functionally in a fast-paced environment
• Detail-oriented with high analytical and problem-solving capability
• Experience with regulatory software submission platforms and tools