Compliance Specialist

20 hours ago

Kanpur, Uttar Pradesh, India beBeecompliance Full time ₹ 8,00,000 - ₹ 12,00,000

Job Summary:

We are seeking a Compliance Specialist to join our team. As a key member of our quality management system, you will be responsible for ensuring that our products meet the highest standards of quality and regulatory compliance.

About this role:
  • Implement and maintain a Quality Management System (QMS) to ensure products meet quality, safety, and regulatory standards.
  • Identify, interpret, and ensure adherence to relevant medical device regulations for market entry and ongoing compliance.
  • Create, review, and control technical files, regulatory submissions, quality agreements, and internal procedures.
  • Provide QA/RA input and support for design and development activities to ensure compliance from the outset.
  • Participate in risk management activities throughout the product life cycle to identify and mitigate potential hazards.
  • Monitor device performance in the market, investigate customer complaints and non-conformity, and manage vigilance reporting.
  • Support the management of supplier quality and compliance.
  • Conduct internal audits and lead initiatives to improve processes and ensure adherence to QMS requirements.
Key Skills & Qualifications:
  • Regulatory Expertise: Deep knowledge of global medical device regulations and standards.
  • Problem-Solving & Attention to Detail: Crucial for interpreting regulations, documenting processes, and resolving issues.
  • Communication Skills: To coordinate with internal departments and external stakeholders.
  • Bachelor's Degree: In a relevant field such as engineering, life sciences, or a related technical discipline.
  • Experience: Previous experience in QA/RA within the medical device industry is an advantage.

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