We are seeking a highly skilled Regulatory Affairs Qualified specializing in Image processing software applications for Computer Tomography (CT). The ideal candidate will have strong expertise in global regulatory requirements for Software as a Medical Device (SaMD), including submission strategies, software lifecycle compliance, and post-market activities. This role demands close collaboration with R&D; (Software Development), Quality, and Marketing teams to ensure smooth regulatory pathways and post-market compliance.
Key Responsibilities
Lead and execute regulatory submissions CT Image processing software applications across multiple regions, including China, 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 and regulatory dossiers for CT Image processing software applications.
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 software design and development phases to mitigate risks and ensure compliance from early stages.
Monitor evolving regulations and guidance related to SaMD, AI/ML (if applicable), and cybersecurity, and ensure timely implementation
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.
3 -6 years of experience in regulatory affairs within the medical device industry, specifically with SaMD. Experience with China NMPA submissions is an added advantage.
Proven track record in preparing and submitting regulatory dossiers to notified bodies and regulatory agencies.
Deep understanding of regulatory frameworks and standard