Regulatory Affairs Specialist

3 hours ago


India OMC Medical Limited Full time

About the Role

This is a full-time on-site position for a Regulatory Affairs Associate at OMC Medical Limited. The successful candidate will be responsible for handling regulatory documentation, ensuring regulatory compliance with medical devices and cosmetics regulations, and managing overall regulatory affairs.

Key Responsibilities

  • Preparing and reviewing regulatory documentation, including EU MDR and FDA submissions.
  • Conducting audits to ensure compliance with regulations and standards.
  • Liaising with government officials, particularly CDSCO, to ensure timely submissions and approvals.
  • Familiarity with medical device and cosmetics regulations and standards in India.

Requirements

  • Bachelor's degree in a relevant field (e.g., life sciences, regulatory affairs).
  • At least 3 years of experience in a similar role, preferably in the medical device industry.
  • Excellent communication and organizational skills, with attention to detail.
  • Ability to work effectively in a team environment and adapt to changing priorities.

Compensation and Benefits

The estimated salary for this role is ₹800,000 - ₹1,200,000 per annum, depending on experience. In addition to a competitive salary, the successful candidate will receive benefits, including health insurance, retirement plan, and opportunities for professional growth and development.



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