Regulatory Compliance Manager

6 days ago


Uppsala, Uppsala, Sweden Rarity Bioscience Full time

Quality Expertise

We are seeking an experienced Quality Specialist to join our team at Rarity Bioscience. As a key member, you will be responsible for ensuring the highest standards of quality and regulatory compliance across our operations.

Key Responsibilities

  • Quality Management System: Implement and maintain our ISO 13485 quality management system to ensure medical device compliance.
  • Document Control: Manage document and record control to maintain accuracy and efficiency.
  • Quality Control and Batch Release: Oversee quality control and batch release to guarantee product quality and consistency.
  • Regulatory Compliance: Ensure compliance with relevant laws, regulations, and industry standards.
  • Audit Coordination: Coordinate internal, external, and supplier audits to ensure compliance.
  • Training and Development: Train team members on quality systems and procedures to enhance their skills.

Benefits

We offer a competitive salary and benefits package, including opportunities for professional growth and development within our agile work environment.



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