Compliance Specialist

2 weeks ago

Chennai, Tamil Nadu, India beBeeQuality Full time ₹ 15,00,000 - ₹ 25,00,000

Our ideal candidate will have a strong background in ensuring product compliance with regulatory standards, including ISO 13485.

In this role, you will be responsible for designing and implementing quality management systems (QMS) to ensure products meet the highest quality, safety, and regulatory standards. This involves identifying, interpreting, and adhering to relevant medical device regulations for market entry and ongoing compliance.

Main Responsibilities:

  • Quality Management Systems: Implement and maintain a QMS to guarantee conformity to ISO 13485 and other relevant regulations.
  • Regulatory Compliance: Ensure adherence to relevant medical device regulations through accurate identification, interpretation, and implementation.
  • Documentation and Reporting: Develop, review, and control technical files, regulatory submissions, quality agreements, and internal procedures to ensure transparency and accountability.
  • Design and Development Support: Collaborate with cross-functional teams to ensure compliance from the outset of design and development activities.
  • Risk Management: Participate in risk management activities throughout the product life cycle to identify and mitigate potential hazards.
  • Device Performance Monitoring: Monitor device performance in the market, investigate customer complaints and non-conformity, and manage vigilance reporting to address emerging issues.
  • Supplier Quality Management: Oversee the management of supplier quality and compliance to guarantee consistency and reliability in sourced materials.
  • Process Improvement: Conduct internal audits and lead initiatives to enhance processes and ensure adherence to QMS requirements, fostering a culture of continuous improvement.

Requirements:

  • A degree in a relevant field such as engineering, life sciences, or a related technical discipline.
  • Strong knowledge of global medical device regulations and standards.
  • Excellent problem-solving and analytical skills for interpreting regulations, documenting processes, and resolving complex issues.
  • Effective communication and coordination skills to work with internal departments and external stakeholders.

We Offer:

  • A competitive compensation package and benefits.
  • Ongoing professional growth and development opportunities.
  • A dynamic and supportive work environment that encourages collaboration and innovation.

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