Medical Device Compliance Specialist

5 days ago


Delhi, Delhi, India Nipro Medical India Full time

Job Summary:

Nipro Medical India Pvt Ltd is seeking a skilled Medical Device Compliance Specialist to manage and oversee the complaint handling process for our medical devices.

Key Responsibilities:

  • Manage the intake, investigation, and resolution of customer complaints related to medical devices.
  • Ensure compliance with CDSCO regulations, ISO standards, and company policies throughout the complaint handling process.
  • Conduct thorough investigations of complaints, including root cause analysis and corrective action implementation.
  • Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to address product issues and improve quality.
  • Prepare and maintain detailed documentation of complaint investigations and resolutions in accordance with regulatory requirements.
  • Monitor and analyse complaint trends to identify areas for improvement and develop preventive actions.
  • Serve as the primary point of contact for regulatory agencies regarding complaint-related inquiries.
  • Provide training and support to internal teams on complaint handling procedures and compliance requirements.
  • Assist in the preparation of reports for management review and regulatory submissions.

Requirements:

  • Bachelor's degree in Life Sciences, Engineering, Quality Assurance, or a related field.
  • Minimum of 5 years' experience in complaint management, quality assurance, or regulatory affairs within the medical device industry.
  • Strong knowledge of CDSCO (Medical Device regulations), ISO 13485 , ISO 27001 , QMS, Risk Management and other relevant quality standards.
  • Excellent analytical, problem-solving, and communication skills.
  • Ability to work collaboratively in a team environment and manage multiple priorities.
  • Proficient in using quality management systems and complaint handling software.

Benefits:

  • Competitive salary of ₹1,200,000 per annum, performance-based bonuses, rewards, and recognitions.
  • Comprehensive insurance health, life, and accident benefits.
  • Opportunities for professional development and career advancement.


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