For the development and expansion of our European sales office in Weiterstadt (near Darmstadt), we are looking for you immediately as a Regulatory Affairs Specialist (m/f/d). At SprintRay, we foster a close working relationship where innovative people have the freedom to find creative solutions to difficult problems. Our open corporate culture and communicative environment help ensure that our work makes a difference. The Regulatory Affairs Specialist in Europe will work with the product development and manufacturing management to ensure that the product development process meets all applicable European regulatory requirements.
- You coordinate with regulatory, product development, and R&D teams in the US to request, develop, and prepare required data and reports to be submitted to European regulatory bodies and agencies
- You establish and maintain business relationships with officials in European government regulatory agencies
- You coordinate inspection of SprintRay organization in Europe and develop procedures to ensure regulatory compliance
- You serve as a representative for the European regulatory affairs team at process review meetings
- You are an expert in the current European regulation process for medical devices (EU MDR) which require governmental approval, including filing necessary applications and handling all government interactions
- You have at least two years of regulatory experience
- You have good knowledge of the European regulations for medical devices
- You have excellent written and verbal communication skills
- You have successfully completed a Bachelor’s degree in related field required
- You speak fluently German and English
- You are a team player, but you also like to work independently
What we offer you:
- A varied and challenging role in which you can help shape and implement your own ideas
- Working in a dedicated team with open communication in a motivating work environment in a growing technology company
- Our modern and open offices in Weiterstadt (near Darmstadt) are located in an attractive business park together with a gym, restaurant (from 2022), daycare center and close to the Loop 5 shopping center and other specialty markets
- Independent work with flat hierarchies and short decision-making paths and thus a wide range of development opportunities
- Flexible working hours
- Adequate performance-related remuneration
- Opportunities for further training and qualification
- Free snacks and drinks
- Extensive training and colleagues who are available to answer questions
The SprintRay team is growing rapidly. Working in an internationally positioned, successful startup, you will be involved in a variety of challenging, interesting projects with development potential.
If you are a tireless problem solver who wants to shape the future of dental 3D printing, join SprintRay!
Together we can revolutionize dentistry and support future generations of doctors, dental technicians and medical device manufacturers around the world.
We look forward to receiving your detailed application including salary expectations and start date.