Noscendo
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Noscendo rekrutiert für Positionen:

Regulatory Affairs Manager

Anforderung

  • Minimum of 2 years of experience in regulatory affairs and/or quality management within the pharmaceutical, medical device, or biotechnology industry
  • Attention to detail to ensure accuracy and thoroughness in regulatory submissions and quality documentation
  • Effective communication of regulatory and quality information to various stakeholders
  • Ability to adapt to changes in regulatory and quality requirements
  • Strong analytical and problem-solving skills
  • Bachelor’s degree in a scientific discipline . Advanced degree or additional certification in regulatory affairs or quality management is a plus
  • Excellent written and verbal communication skills
  • Ability to manage multiple tasks and priorities

Verantwortlichkeiten

  • Support the development, implementation, and maintenance of the Quality Management System in accordance with applicable standards
  • Assist in conducting internal audits and support external audits and inspections
  • Help oversee corrective and preventive actions and ensure timely resolution of quality issues
  • Monitor and report on key quality metrics and trends
  • Support continuous improvement initiatives and promote a culture of quality within the organization
  • The Junior Quality Management & Regulatory Affairs Manager is responsible for ensuring that the company's products comply with all regulations and standards in the target markets
  • Collaborate with cross-functional teams to ensure regulatory and quality requirements are integrated into product development
  • Assist in the development and delivery of training programs related to regulatory and quality compliance