Regulatory Affairs Specialist

20 hours ago


Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 90,00,000 - ₹ 1,20,00,000
Regulatory Affairs Specialist

This role is a great opportunity for individuals with a strong understanding of regulatory affairs and a passion for ensuring compliance. The Regulatory Affairs Specialist will play a critical role in assisting international regulatory teams with navigating evolving business needs in the Indian market.

Key Responsibilities:
  • Collaborate with international regulatory teams to ensure alignment with business objectives.
  • Provide guidance on India MDR requirements, ensuring effective communication with stakeholders.
  • Regularly meet with regulatory teams to understand evolving business needs and provide solutions-oriented support.
  • Facilitate communication with CDSCO and other regulatory officers to clarify regulatory requirements.
  • Evaluate and recommend technology platforms to manage licenses and process flows for multiple operating companies.
  • Minimize risk to business disruption from regulation through agile and responsive support.
  • Utilize MTAI membership effectively for advocacy and positioning Halma's point of view.
Requirements:
  • Degree in Regulatory Management or related field.
  • Minimum 1-3 years of relevant experience in regulatory affairs.
  • Core end-to-end experience in India MDR.
  • Experience with regulatory license platforms.
  • Exposure to legal metrology, labeling, UDI, MRP/Pricing/Trade Margins, Customs, and other related operational issues.
  • Advantageous: exposure to European MDR and FDA regulations.


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