Careers

Job Overview:-

Operon Strategist is inviting applications for the position of Regulatory Affairs Specialist to join our regulatory team. If you have experience in SIMD/SaMD regulatory submissions, Medical SDLC documentation, and global regulatory compliance, this role offers an excellent opportunity to work with a leading medical device consulting firm. 

• Job Title: Regulatory Affairs Specialist – SaMD / Digital Health
• Location: Pune
• Education: Bachelor’s degree in Biomedical Engineering, IT, Computer Engineering, or a related field
• Experience: 1 to 4 years of Regulatory Affairs experience (SaMD/Digital Health preferred)

✨ Key Responsibilities: 

• Preparing, compiling, and submitting regulatory documentation for FDA 510(k), CE Marking (MDR), UKCA, and other global submissions
• Ensuring SaMD development complies with IEC 62304, ISO 14971, ISO 13485, ISO 27001, and relevant cybersecurity standards
• Maintaining up-to-date knowledge of global SaMD regulations including FDA guidance, EU MDR Annex VIII, IMDRF SaMD frameworks
• Supporting design and development documentation including risk management, clinical evaluation, labeling, and technical files
• Managing regulatory communication with Notified Bodies, Competent Authorities, and other regulatory agencies
• Supporting post-market surveillance, vigilance reporting, and compliance activities
• Participating in internal and external audits and inspections
• Monitoring evolving global regulatory requirements and communicating their impact to internal teams

👉 Key Skills: 

• Strong knowledge of global SaMD regulatory frameworks
• Excellent written and verbal communication skills
• Ability to interpret technical documentation and translate regulatory requirements into actionable tasks
• Strong organizational, analytical, and project management abilities
  

💡 Preferred: