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inveox

Head of Regulatory Affairs & QM (m/f/d)

Garching bei München

About us

Whether it is attention to the detail of two perfectly interlocking gears or the enthusiasm with new technology to change the customer's world -everyone has its own drive. Nevertheless, we all have a desire to make Cancer diagnoses more reliable and faster, whether from personal experience or simple devotion to the underlying technology. Every day one step closer to our goal.

Your tasks

You are thrilled to work for a company with high ethical values and would love to have an immense impact on people’s lives by helping release our products?
As our Head of Regulatory Affairs & QM (m/f/d) you’ll lead our Regulatory Affairs & QM team and ensure that our company and our products fulfil the respective national and international regulatory requirements in order to apply successfully for a CE/FDA certification.

  • You are responsible for national and international Medical Device certification application processes and the registration of our products in cooperation with our Product & Technology Teams
  • You are responsible for the certification and registration process from approval strategy to documentation, in line with the medical device certification requirements (e.g. ISO, IVDR, MDR, FDA, CFDA) as well as applicable (harmonized) standards
  • You plan and carry out clinical trials as part of product release procedures in cooperation with our interdisciplinary project team as well as external partners
  • You identify / foresee regulatory requirements and changes (up-to-date regulatory strategy, reaching strategy goals) in order to ensure that our technical product files are up-to-date and comply to the regulatory requirements
  • You are responsible for the product-related risk management, from systematically identifying the current state-of-the-art to post-release risk analysis
  • You own and oversee our eQMS operations and associated procedures to enable compliance to applicable regulations
  • You make sure that our products comply with all applicable global and regional regulatory requirements from labeling over performance to safety elements as well as post market surveillance procedures
  • You supervise, guide and lead a growing team of regulatory affairs and quality management specialists to achieve high quality product launches and post market success

Requirements

  • You have completed your university education in a scientific or other relevant field 
  • You have several years of professional experience in the field of Regulatory Affairs of Medical Devices and experience with approval procedures like CE or FDA for IVD in Europe/US
  • You have extensive experience in the cooperation with Notified Bodies as well as respective health and approval authorities in Europe, US and/or China
  • You have gained leadership experience as leader of a project team or department
  • You ideally have a Regulatory Affairs Certification (e.g. TÜV, etc.) or are keen to complete this with us
  • You are highly communicative and able to manage information flows across departments and third parties
  • You enjoy working in a very accurate way and have a meticulous love for detail
  • You have a high affinity to high-tech-products and startups in MedTech
  • You have excellent written and spoken English and German skills

Why inveox?

  • To the top: At inveox, we don't see our employees as resources, but as talents! That's why we offer you many opportunities for personal and professional development
  • Work-Life-Harmony: We support you in achieving the best performance through flexible working time models and home office option
  • Meet & Mentor: You will work in a highly entrepreneurial environment with experienced professionals, have the opportunity to meet renowned industry experts and receive an introduction to the German start-up scene
  • Learn & Grow: In addition to support within and outside your team, you will receive regular feedback and personal coaching as well as methodical and practical training to promote your professional growth
  • Team Spirit: Enjoy daily team lunches, a Christmas and summer party and lots of team events

Interesse geweckt?

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