Senior Regulatory Compliance Specialist

2 weeks ago

Hyderabad Secunderabad Telangana Mumbai Kolkata, India beBeeCompliance Full time ₹ 1,04,000 - ₹ 1,30,878

The primary responsibility of this role is to ensure compliance and availability of X-ray generation subsystems for CT scanners in global markets.

This position requires a high degree of collaboration with cross-functional teams to lead or support compliance activities for medical device regulations.

  • Responsibilities include reviewing regulatory compliance change notifications, driving associated actions, leading compliance efforts to various global regulations, and supporting product regulatory documentation updates.
  • Additionally, this role involves supporting regulatory audits and inspections to ensure post-market surveillance compliance.

Qualifications we seek in a candidate

Required Skills and Qualifications

  • Knowledge of medical regulations including FDA, EU MDR, NMPA/CFDA, and other applicable international regulations
  • Understanding of regulatory standards such as IEC 60601, ISO13485, 14971, and other relevant standards
  • Excellent communication and collaboration skills, with proficiency in interpreting complex regulations and preparing associated documentation
  • Bachelor's degree in engineering, science, or a related field, with minimum two years of experience working with medical devices regulations and quality management systems
  • Proficiency with written English and a neutral accent

Preferred Qualifications/ Skills

  • Strong technical knowledge, effective probing skills, and analyzing/understanding skills
  • Attention to detail and ability to analyze complex information

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