SaMD/SIMD Regulatory Affairs Executive

SaMD/SIMD

Key Responsibilities:

• Prepare, compile, and submit regulatory documentation for SaMD/SIMD products, including 510(k), CE marking (under MDR), UKCA, and other global regulatory submissions.
• Ensure SaMD product development and maintenance align with relevant standards such as

  IEC 62304

  ,

  ISO 14971

  ,

  ISO 13485

  ,

  ISO 27001

  , and applicable cybersecurity guidance.
• Maintain up-to-date knowledge of regulatory requirements and guidance related to SaMD (e.g., FDA’s premarket guidance, EU MDR Annex VIII, IMDRF SaMD framework).
• Provide regulatory input into product design and development documentation, including risk management, clinical evaluation, and labeling.
• Manage regulatory interactions with notified bodies and competent authorities.
• Support post-market surveillance, adverse event reporting, and regulatory compliance activities.
• Participate in audits and inspections.
• Monitor changes in global regulations and communicate impact to internal stakeholders.
•  

Qualifications:

Education:

• Bachelor’s  Biomedical Engineering, Information Technology, Computer Engineering or a related field.

Experience:

• 1-4 years of experience in regulatory affairs, preferably with a focus on

  SaMD or Digital Health

  .
• Hands-on experience with regulatory submissions in key markets (FDA, EU, UK).
• Familiarity with software development lifecycle and documentation for regulated medical software.
• Experience working in a regulated environment (ISO 13485, QMS).

Skills:

• Strong knowledge of global SaMD regulatory frameworks.
• Excellent written and verbal communication skills.
• Ability to interpret technical documentation and translate regulatory requirements clearly.
• Strong organizational and project management abilities.

Preferred:

• Experience with Agile software development.
• Knowledge of AI/ML in SaMD and associated regulatory considerations.

How to Apply :

Send your CV on hr@operonstrategist.com or reach out via WhatsApp on 7822919196