Quality Management & Regulatory Affairs Manager (f/m/d)

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SzeleSTIM is an innovative start-up developing cutting-edge medical technology for chronic pain management, based upon years of scientific and clinical expertise. We help patients to recover and actively shape their lives with our solutions for auricular vagus nerve stimulation.

For our ambitious and fast-growing team with headquarters in Vienna, Austria, we are looking for a

Quality Management & Regulatory Affairs Manager (f/m/d)

Full-time, as soon as possible

Your tasks:

  • Lead, organization and execution of all QM and RA topics of the company
  • Responsible for all steps towards CE approval of our product portfolio and implementation of a full QM system according to ISO 13485:2016
  • Coordination of the RA and QM pathway with the notified body and regulatory authorities
  • Coordination of all activities at the interface with R&D, clinical development, product management, sales, and marketing
  • Assurance of regulatory compliance of all processes and the product portfolio
  • Targeted support to ensure an efficient process design, as well as process-oriented communication in the company and to authorities
  • Organization and execution of management reviews
  • Preparation, execution and follow-up of QM system certification audits, as well as inspections by authorities of the QM system and the technical file of our product portfolio
  • Planning and execution of regular internal audits and supplier audits
  • Build-up of the QM and RA team of the company including budgeting, monitoring, action planning and personnel planning

Your qualifications:

  • Degree in natural or technical sciences, business administration (MSc, PhD, MBA)
  • Knowledge in implementing regulatory requirements according to the Medical Device Directive (93/42/EWG) and the Medical Device Regulation (EU) 2017/745
  • Expertise in establishing a QM system according to ISO 13485:2016
  • At least 5 years dedicated professional experience in the medical device industry
  • Business fluent in German and English
  • Proven management experience with strong cross-functional relationship building skills
  • Solution-oriented and analytical thinking to understand complex processes
  • Enthusiastic and inquiring team player with a high degree of flexibility

Our offer :

  • Shape the quality management and regulatory landscape of an aspiring start-up
  • Dynamic role in a highly motivated team on the way to market leadership
  • The formal minimum annual salary according to the collective bargaining agreement for this position is EUR 46.214,00, willingness to overpay according to the qualifications and experience of the successful candidate

We look forward to receiving your application via mail to jobs@szelestim.com.

SzeleSTIM GmbH
Schlagergasse 2/18
1090 Vienna
Austria
Web: www.szelestim.com

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