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Employee in quality management and/or regulatory affairs

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Brainlab

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Location:
Austria , Salzburg

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Category:
Quality Control

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Contract Type:
Employment contract

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Salary:

Not provided
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Job Description:

As a professional QM/RA associate, you will be responsible for tasks in Quality Management and Regulatory Affairs for medical imaging solutions and devices.

Job Responsibility:

  • Support and collaborate across all areas of Quality Management (QM)
  • Ongoing control, improvement, and optimization of quality management processes and standards
  • Assist in creating and reviewing deviation reports, risk management plans, and CAPA (Corrective and Preventive Actions), ensuring thorough monitoring of corrective actions
  • Ensure the implementation and monitoring of regulatory requirements for medical devices
  • Assist with international product certifications and approvals
  • Liaise with regulatory bodies and authorities, including correspondence with notified bodies (globally)
  • Support clinical evaluations, ensuring that medical devices meet clinical safety and performance requirements in accordance with regulatory standards
  • Participate in post-market surveillance activities, including monitoring product performance in the market and managing feedback loops to continuously improve device safety and effectiveness
  • Support internal and external audits as well as supplier audits
  • Assist R&D with documentation and support the development process

Requirements:

  • Experience or training in Quality Management, preferably in the medical device sector (ISO 13485) or any industry with high regulatory standards
  • Knowledge of EU MDR (Medical Device Regulation) and experience with Class II or higher medical devices is an advantage
  • Familiarity with clinical evaluations and post-market surveillance processes under MDR guidelines is highly desirable
  • Knowledge of international regulations and certifications for medical devices is a plus
  • Fluent in German and English (written and spoken)
  • Flexible, team-oriented, and eager to work in an international environment

Nice to have:

  • Knowledge of EU MDR (Medical Device Regulation) and experience with Class II or higher medical devices
  • Familiarity with clinical evaluations and post-market surveillance processes under MDR guidelines
  • Knowledge of international regulations and certifications for medical devices
What we offer:
  • A motivating work atmosphere in a young, dynamic team
  • An exciting and varied scope of assignments customized for your skills and interests
  • The opportunity to grow with us, be directly involved and participate in our company’s success
  • A secure, permanent full-time contract
  • Generous social benefits within our culturally diverse enterprise
  • Freshly-cooked meals and healthy snacks provided daily
  • Good public transport connections and parking facilities available
  • Flexible working hours
  • Support for daily obligations (childcare, etc.)

Additional Information:

Job Posted:
December 28, 2025

Employment Type:
Fulltime
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