Regulatory Compliance Specialist

8 hours ago

Pune, Maharashtra, India beBeeRegulatoryEngineer Full time ₹ 15,00,000 - ₹ 28,00,000
Job Title: Regulatory Engineer

Our team is seeking a highly motivated and experienced Regulatory Engineer to join us in ensuring compliance and availability of our medical devices for global markets.

This role will involve working with cross-functional teams to lead or support compliance activities, reviewing regulatory compliance change notifications, and driving associated actions to ensure timely compliance. You will also be responsible for leading compliance efforts for various global regulations, product regulatory documentation updates, and supporting regulatory audits and inspections.

Key Responsibilities:
  • Collaborate with engineering, manufacturing, regulatory, sourcing, and other teams to ensure compliance with medical device regulations.
  • Review and drive action on regulatory compliance change notifications to ensure timely compliance.
  • Lead compliance efforts for global regulations, including REACH and ROHS, in alignment with the quality management system.
  • Update product regulatory documentation, such as NRTL reports and tech files.
  • Support regulatory audits and inspections to ensure post-market surveillance compliance.
Requirements:
  • Knowledge of medical regulations, including FDA, EU MDR, NMPA/CFDA, and other applicable international regulations.
  • Knowledge of regulatory standards, such as IEC 60601, ISO13485, 14971, and other applicable standards.
  • Proficiency in interpreting and applying complex regulations, preparing associated documentation.
  • Excellent interpersonal communication and collaboration skills.
  • Bachelor's degree in engineering, science, or related field.
  • Minimum 2 years of experience working with medical devices regulations and quality management system.
Preferred Qualifications:
  • Strong technical knowledge.
  • Effective probing skills and analyzing/understanding skills.
  • Strong attention to detail.

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