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 1300 dedicated and inspiring individuals in 19 offices worldwide. To succeed in reaching our targets, we are seeking committed colleagues who can stand behind our core values of inspiration, simplicity and integrity (m/w):

Quality Management Associate (m/f/d) – Regulatory Affairs


WHAT TO EXPECT

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. You will interpret regulatory requirements and implement them in projects and/or processes.

Your duties include:

  • Review Technical Files / Design Dossiers before CE marking a new/changed product
  • Evaluate product design changes and accompany their implementation
  • Establish global regulatory strategies for Brainlab products in collaboration with local partners in our subsidiaries
  • Compile regulatory submissions e.g. 510(k) submissions to FDA, Import License submission to Asian authorities
  • Monitor & investigate regulatory requirements for defined countries
  • Contribute and collaborate in adapting the Brainlab Quality System to new/changing regulatory requirements
  • Participate in regulatory agency audits
  • Train Brainlab employees in regulatory requirements

WHAT YOU OFFER

The ideal candidate will have

  • 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 a plus
  • Excellent English written and verbal communication skills including presentation skills
  • Persuasive power
  • Good MS Office knowledge

READY TO APPLY?

We offer you a professional business environment, an international team and a performance-oriented environment as a base to consequently realize your ideas. Through distinguished training, efficient education and the regular exchange of experience with colleagues from different departments, you will be demanded and promoted, both professionally and personally.

Interested? Then we are looking forward to receiving your online application including your start date and salary expectation!

Contact person: Géraldine Endres