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QM Associate – Regulatory Affairs (Software devices)

Quality Management Mid-Senior Level Munich, BY, Germany

Founded in Munich, Germany in 1989, Brainlab develops, manufactures and markets software-driven medical technology, enabling access to improved, more efficient, less-invasive patient treatments. Our key to success is our creative, talented and hard-working team, which consists of around 2000 dedicated and inspiring individuals in 25 locations worldwide. To succeed in reaching our targets, we are seeking committed colleagues who can stand behind our core values curious, authentic and useful:

Job Description

You are interested in Regulatory Affairs or in the development of medical devices?

As QM Associate - Regulatory Affairs you will interact with Brainlab departments and partners internationally and Regulatory Agencies from all over the world. In a cross-functional team you will be involved in the development of various Brainlab products and be responsible for establishing the regulatory strategy. This role focuses exclusively on Software as a Medical Device (SaMD). You will interpret regulatory requirements and implement them in projects.

Your duties include:

  • Review Technical Documentation before CE marking a new/changed medical device
  • Evaluate and follow up design changes during the development and implementation
  • Discuss regulatory topics with R&D colleagues and other departments
  • Establish global regulatory strategies for Brainlab medical devices in collaboration with local partners in our subsidiaries
  • Compile regulatory submissions to be send to authorities e.g. 510(k) submissions to FDA, the Notified Body and other authorities
  • Monitor & investigate regulatory requirements in pre-defined countries
  • Participate in regulatory audits and follow up improvement opportunities
  • Train Brainlab employees in regulatory requirements

Qualifications

  • Degree in engineering or life sciences preferred, but other degrees may be considered
  • Professional experience in regulatory affairs or regulatory compliance in the medical device field is an advantage. Previous experience in other departments related to the development of a medical device is a plus (e.g. in R&D)
  • Knowledge of medical device software and related regulatory requirements (e.g. IEC 62304, IEC 82304, ISO 14971, cybersecurity) is a plus
  • Excellent English written and verbal communication skills
  • Ability to communicate with all stakeholders
  • Persuasive power

Additional Information

  • A mutually-supportive, international team
  • Meaningful work with a lasting impact on medical technology
  • 30 vacation days, plus December 24th and December 31st
  • Flexible working hours
  • Parking garage and safe underground bike storage
  • Award-winning subsidized company restaurant and in-house cafes
  • Variety-rich fitness program in our ultra-modern 360m2 company gym
  • Regular after work, team, and company events
  • Comprehensive training and continuing education opportunities

Ready to apply? We look forward to receiving your online application including your first available start date and desired salary. 

Apply now

Your HR Contact Person
Géraldine Endres
Senior Recruiter

Géraldine Endres [email protected]

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