Product Compliance Specialist

4 days ago

Ellore, Andhra Pradesh, India beBeeRegulatory Full time ₹ 90,00,000 - ₹ 1,20,00,000
Job Overview

We are seeking a Product Compliance Specialist to ensure our products meet quality, safety, and regulatory standards.

Key Responsibilities:
  • Implementing and maintaining a Quality Management System (QMS) to guarantee product compliance.
  • Ensuring adherence to relevant medical device regulations for market entry and ongoing compliance.
  • Creating, reviewing, and controlling technical files, regulatory submissions, 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.
Benefits:

The successful candidate will have the opportunity to work with a dynamic team and contribute to the development of innovative products that meet regulatory requirements.

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