Regulatory Affairs Associate

7 hours ago


Madurai, Tamil Nadu, India HCLTech Full time ₹ 6,00,000 - ₹ 8,00,000 per year

Preferred candidate profile

Qualifications/ JD:

  • Bachelor's degree in Mechanical / Biomedical / SW /HW Engineering, Quality Assurance, Regulatory Affairs, or a related field.
  • In-depth understanding of medical device regulations, including FDA 21 CFR Part and ISO 13485:2016 requirements for design controls and DHF.
  • Experience with risk management principles (e.g., ISO and their application to DHF.
  • Experience with DHF remediation projects, especially for legacy products and/or in response to regulatory changes.
  • Experience with Quality Management Systems (QMS) software and tools for DHF management (e.g., TcU, SAP PLM) is a plus.


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