Product Compliance Specialist

12 hours ago

Nellore, Andhra Pradesh, India beBeeQuality Full time ₹ 90,00,000 - ₹ 1,20,00,000
Job Responsibilities

We are seeking a highly skilled Quality Assurance Specialist to join our organization. The successful candidate will be responsible for implementing and maintaining a Quality Management System (QMS) that ensures products meet quality, safety, and regulatory standards.

Key Responsibilities:

  • Implementing and maintaining a QMS like ISO 13485.
  • Ensuring adherence to relevant medical device regulations for market entry and ongoing compliance.
  • Creating, reviewing, and controlling technical files, regulatory submissions (e.g., 510(k)), 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 & 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.

This role offers a unique opportunity to work with a talented team and contribute to the success of our organization. If you have the skills and passion to excel in this position, we encourage you to apply.

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