Posted:2 days ago| Platform: Linkedin logo

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On-site

Job Type

Full Time

Job Description

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

 

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