Medical Device Regulatory Compliance Specialist

1 day ago


Allahabad, Uttar Pradesh, India beBeeQualityAssurance Full time ₹ 8,00,000 - ₹ 15,00,000

Quality Assurance Position

We are seeking a highly skilled Quality Assurance professional with expertise in global medical device regulations and standards.

Key Responsibilities:

  • Implementing and maintaining a Quality Management System to ensure compliance with regulatory standards.
  • Identifying, interpreting, and ensuring adherence to relevant medical device regulations for market entry and ongoing compliance.
  • Creating, reviewing, and controlling technical files, regulatory submissions, quality agreements, and internal procedures.
  • Providing QA input and support for design and development activities to ensure compliance from the outset.
  • Participating in risk management activities throughout the product life cycle to identify and mitigate potential hazards.
  • Monitoring device performance in the market, investigating customer complaints, and managing vigilance reporting.
  • Supporting supplier quality and compliance management.
  • Conducting internal audits and leading initiatives to improve processes and ensure adherence to QMS requirements.

Requirements:

  • Regulatory expertise: Deep knowledge of global medical device regulations and standards.
  • Problem-solving skills: Crucial for interpreting regulations, documenting processes, and resolving issues.
  • Effective communication skills: To coordinate with departments and stakeholders.
  • Education: Bachelor's degree in a relevant field such as engineering or life sciences.
  • Experience: Previous experience in QA within the medical device industry is an advantage.

What We Offer

A supportive work environment, opportunities for growth and development, and a competitive compensation package.



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