Quality And Regulatory Compliance Auditor (x|f|m)

Sartorius

Goettingen, Germany
Not specified; attractive compensation including p...
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Master's degree in biotechnology or chemistry
Experience in regulated medical device industry
Knowledge of iso certifications and auditing processes
** Sartorius is seeking a Quality and Regulatory Compliance Auditor to join their Regulatory Affairs and Compliance department, working remotely with occasional onsite requirements in locations across Germany, France, and the UK. The role involves managing quality audit programs, ensuring compliance with regulatory requirements, and contributing to continuous improvement efforts. **

Job Summary

  • The role involves steering the quality audit program across bioprocess solution operations in Goettingen, Aubagne, and Royston.
  • Candidates will ensure regulatory requirements are fulfilled by writing procedures, managing risk assessments, and coordinating responses to deviations.
  • Sartorius offers a comprehensive benefits package including remote work options, 30 vacation days, and a modern campus environment.

Matching Summary

Match Score: 75

** Sartorius is seeking a Quality and Regulatory Compliance Auditor to join their Regulatory Affairs and Compliance department, working remotely with occasional onsite requirements in locations across Germany, France, and the UK. The role involves managing quality audit programs, ensuring compliance with regulatory requirements, and contributing to continuous improvement efforts. **

Salary

Not specified; Attractive compensation including pension benefits with a 35 hr. week; Vacation and holiday bonuses included

Skills & Requirements

Must-have

  • Master's degree in Biotechnology or Chemistry
  • Experience in regulated medical device industry
  • Knowledge of ISO certifications and auditing processes
  • Fluency in German and English languages
  • Ability to prepare regulatory submissions

Nice-to-have

  • Cross-functional international team collaboration
  • Mentoring and supervising team members
  • Willingness to travel approximately 20%
  • Alignment with sustainability and openness values

Key Requirements

  • Master's degree in relevant scientific discipline
  • First years of experience in regulated environment
  • Qualification to act as an auditor in medical device manufacturing
  • Business fluent in German and English

Work Rights

Not specified

Tailored Resume

Cover Letter