QM/RA Consultant - Digital Solutions (m/f/d)

Advise our customers on the implementation of our digital solutions with your expert knowledge in medical technology

YOUR ROLE IN OUR TEAM

Consult: Understand the processes our customers and the regulatory environment in which they operate. Moderate workshops and discuss processes and potential for optimization with process stakeholders. Use your strong communication skills to advise our customers actively and decisively during digitalization projects based on your knowledge and experience in the medical device industry.

Realize: Provide input for new avasis solutions and optimization of our existing solutions. Screen new regulatory documents, understand the regulatory requirements and ensure that our solutions are regulatory complaint and support our customers to efficiently fulfill those.

Support: Internally, you support our sales, development and marketing team with subject-specific questions and conduct internal trainings on new regulatory topics.

YOUR PROFILE
  • Completed engineering degree or comparable.
  • +3 years experience in the medical technology industry, preferably as Quality Manager, Regulatory Affairs Specialist or QM/RA consultant that worked already with software solutions
  • Knowledge and understanding of key regulatory documents/processes such as MDR/IVDR, ISO 13485, 21 CFR Part 820, ISO 14971, IEC 62366.
  • Advantage: Experience as consultant and/or support of digitalization projects
  • Customer oriented thinking, enthusiasm for simplification and focus on efficiency
  • Strong communication and organization skills to manage the communication with customers, e.g. during workshops. Open to share your know-how with customers and colleagues.
  • Willingness to travel internationally for conferences, onsite workshops and projects.
  • Fluent in German and English to work in international projects.
JOIN THE AVASIS GROUP

Our mission: Reduce the effort required to create and maintain documentation with innovative software solutions and digitize processes sustainably.

Based on the established Siemens technology platform, we develop solutions for the medical technology industry and continuously evolve them together with our customers. Our goal: To drive digitalization and enable our customers to use their resources for development of innovative devices instead of wasting them on documentation. avasis is a modern employer and additionally offer:

  • Start-up culture: Flat hierarchy, open & direct communication, fast and reliable team support
  • Flexibility: Work where and when you want (in agreement with the team of course 😉)
  • Team events: Meet your team and the avasis group in changing locations, fun guaranteed
  • Learn & grow: Diversity of projects, customers and internal education programs
  • Make an impact: Support & change one of the most innovative industries - medical technology!

ARE YOU INTERESTED? Join our dynamic team in a continuously growing company and work in one of the most innovative areas – Digitalization! We look forward to receiving your application.

Apply now!

Do you already feel a certain tingling sensation and are you curious and interested in receiving more background information? Then you can apply here.

To the application form
Additional services

With avasis you benefit from numerous advantages. Our services at a glance.

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5 weeks vacation

avasis attaches great importance to a good work-life balance. We offer our employees at least 25 days of vacation per year. 

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Free parking

For stress-free arrival at work, our employees have free parking spaces at their disposal.

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Continuing education

We invest specifically in the training of our employees and promote their continuing education and development.

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Premises

avasis is an innovative and modern company. This is also reflected in our premises. 

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Flexible working hours

The flexitime model allows our employees to benefit from flexible working hours. This way, nothing stands in the way of an evening fitness session or an early start to a vacation.

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Home office

We support working outside of our premises after consultation with your supervisor. This makes “working anywhere” possible.

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Team events

avasis organizes numerous personnel events where employees can exchange ideas, have fun, and relax.

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Meals

We also take care of our employees' nutritional needs. We provide coffee and beverages, and offer discounted lunches. 

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Contact person

For further questions about this exciting challenge, please contact Sarah Panten.

Sarah Panten
Sarah Panten
Strategic Business Development