Senior Compliance Specialist

2 days ago

Udaipur, Rajasthan, India beBeeQuality Full time ₹ 8,00,000 - ₹ 15,00,000
Job Description

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

The Quality Assurance Specialist will also be responsible for ensuring adherence to relevant medical device regulations for market entry and ongoing compliance. This includes creating, reviewing, and controlling technical files, regulatory submissions, quality agreements, and internal procedures.

In addition, the Quality Assurance Specialist will provide QA/RA input and support for design and development activities to ensure compliance from the outset. They will also participate in risk management activities throughout the product life cycle to identify and mitigate potential hazards.

The Quality Assurance Specialist will monitor device performance in the market, investigate customer complaints and non-conformity, and manage vigilance reporting. They will also support the management of supplier quality and compliance.

This is an excellent opportunity for a motivated and detail-oriented individual to join our team and make a real impact on our products and services.

Required Skills and Qualifications

To be successful in this role, you will need:

  • Regulatory expertise: Deep knowledge of global medical device regulations and standards.
  • Problem-solving and 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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