Medical Device Compliance Manager

6 hours ago

Bharatpur, Rajasthan, India beBeeQualityAssurance Full time ₹ 8,00,000 - ₹ 12,00,000
Job Title: Quality Assurance Specialist

This position is crucial in ensuring the quality and compliance of medical devices within the organization. A deep understanding of global medical device regulations and standards, along with excellent problem-solving and communication skills, are required for this role.

Key Responsibilities:
  • Developing and maintaining a comprehensive Quality Management System (QMS) to ensure products meet quality, safety, and 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/RA 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 non-conformity, and managing vigilance reporting.
  • Supporting the management of supplier quality and compliance.
  • Conducting internal audits and leading initiatives to improve processes and ensure adherence to QMS requirements.
Required Skills and Qualifications:
  • Regulatory Expertise: In-depth knowledge of global medical device regulations and standards.
  • Problem-Solving & Attention to Detail: Essential for interpreting regulations, documenting processes, and resolving issues.
  • Communication Skills: To coordinate with internal departments and external stakeholders effectively.
  • 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 highly advantageous.

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