11/10/2022 | sync2brain GmbH

Quality- and Regulatory Affairs Manager (w, m, d)

You want to benefit from synergies between working in a start-up and coaching start-ups in
parallel?
You want to develop yourself and your workplace?
You want to have responsibility instead of only fulfilling tasks created by others?
You want to have a broader field than only QARA?
You want to combine organizational, strategic work with regulatory deep dives and working
with regulated documents?


sync2brain is a start-up based in Tübingen, which commercializes a novel technology that for the first time enables effective, personalized therapy for patients with stroke or depression – with much less side-effects compared to conventional therapy. Their bossdevice combines devices for electroencephalography (EEG) with devices for transcranial magnetic stimulation (TMS) of the brain. It synchronizes the stimulation to the individual brain state making TMS most effective. The bossdevice is already available for researchers and will be certified as a medical device in the coming months. The long-term goal is to establish bossTMS therapy as a standard procedure for the treatment of stroke, depression and other neuropsychiatric disorders.

The Medical Innovations Incubator is a wholly owned subsidiary of the non-profit “Foundation for Medical Innovation”, Tübingen. As an extended operative arm of the foundation, it practically implements the foundation’s purpose of promoting medical innovations. In doing so, we see ourselves as a specialized platform for medical innovations. We connect everyone who is interested in the topic of innovations in the field of medical life science. With our expertise, Accelerator-Programm, our services for startups and corporates, events and our highly specialized network, we provide the right offer for startups and all other stakeholders. For the next possible date, we are looking for a Quality- and Regulatory Affairs Manager (w, m, d).


Your tasks at sync2brain

  • implementation, maintenance and improvement of the quality management system according to ISO 13485
  • certification of medical devices according to the MDR and FDA including the relevant technical documentation
  • planning and implementation of other applicable certifications
  • close cooperation with and support of our team for clinical affairs and technical development


Your tasks at Medical Innovations Incubator

  • development of products and services for start-ups in the field of Quality Management and Regulatory Affairs / QARA.
  • coaching of start-ups regarding QARA
  • represent and communicate Regulatory Thinking® (www.regulatorythinking.de)
  • develop an overall business strategy together with start-ups
  • Support of projects with corporates
  • Speaker in some of our events like e.g. the 4C Accelerator


Your qualifications

  • university degree in biomedical engineering, pharmacy, medicine, or related fields
  • at least two years of professional experience in Quality Assurance and Regulatory Affairs of medical devices
  • profound knowledge in Medical Device regulations in Europe, especially Germany and/or the US
  • open to work in a dynamic and flexible environment that can be actively shaped
  • strong, positive and responsible personality
  • proactive and self-reliant working style
  • organizational talent and attention to detail with a sense for priorities
  • open and direct communication style as well as distinct team spirit
  • ability to work effectively in multinational/multicultural environment
  • fluent in English and German


Framework conditions
• The position will be shared between the two companies and is planned as 80-100% position
• combination of on-site work in our co-working space in Tübingen and remote work is possible with a flexible working schedule

Are you interested?

Please send your application to haemmerle@mi-incubator.com and ramona.samba@sync2brain.com

 

Further Information:

https://sync2brain.com/

http://mi-incubator.com