Regulatory Affairs Specialist

3 hours ago


New Delhi, India OMC Medical Limited Full time

Role Description  


This is a full-time on-site role for a Regulatory Affairs Associate at OMC Medical Limited. The Regulatory Affairs Associate will be responsible for handling regulatory documentation, ensuring regulatory compliance, understanding regulatory requirements, preparing regulatory submissions, and managing overall regulatory affairs for medical devices and cosmetics. 


Qualifications  


  • Experience in regulatory and quality documentation preparing and reviewing.  
  • Experience in EU MDR or FDA documentation and submission  
  • Experience in conducting auditing 
  • Familiarity with medical device and cosmetics regulations and standards 
  • Attention to detail and strong organizational skills 
  • Ability to work effectively in a team environment 
  • Bachelor's degree in a relevant field (e.g., life sciences, regulatory affairs, etc.) 
  • Experience in the medical device and cosmetics industry is a must. 
  • Experience with liaising with government officials, particularly CDSCO, is a must. 

 

Location  


Delhi, India 


Ideal Candidate  


Should have: 


  • Full driving license 
  • Good English-speaking skills 
  • Self-starter attitude 
  • 3 years of experience in a similar field with exposure to CDSCO in medical devices and cosmetics. 

 



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