Regulatory Affairs Manager - Medical Devices (m/f/d)

Legal · Pforzheim · Full-time · Mid-level

Job description

Job description

About the Job

We’re looking for a motivated Regulatory Affairs Manager (m/f/d) to join one of our portfolio companies in their R&D Department and play an integral role in the registration of their non-active medical devices in a global context.  

In your day-to-day work, you’ll focus on driving the development of new and existing products through formulating regulatory strategies, conducting technical documentation and ensuring compliance in regards to international and, in particular, Medical Devices Regulations (MDR) regulations. 

Join our portfolio company: An Austrian MedTech company focused on manufacturing dental CAD/CAM equipment and materials. This leading pioneer of digital dental technology has offices across the globe.

In this role, you’ll:

  • Plan, create and maintain technical documentation for medical devices in accordance with Regulation (EU) 2017/745 (MDR) for dental restorative materials and the associated product portfolio in English
  • Ensure compliance with international legal and regulatory requirements for medical devices 
  • Conduct independent research and implement legal requirements
  • Develop regulatory strategies for new medical devices - keeping timing and cost effectiveness in mind 
  • Collaborate with the product management, R&D and quality management departments
  • Build relationships within specialist/industry specific groups in Germany and abroad, and participate in industry related events (eg. IDS - Dental Industry and Dental Trade Fair)

Your Profile

  • Professional experience in regulatory affairs management within the medical technology and/or devices industries
  • Advanced knowledge of Medical Devices Regulations (MDR) in theory and practice
  • Well versed in technical documentation for medical devices and a strong affiliation for technology
  • Independent, structured and attentive way of working with strong organisational skills and a great team spirit 
  • Solution-oriented approach and a high willingness to learn
  • Experience with EU and USA legal requirements and product approval considered an advantage
  • Experience in the areas of quality management according to DIN EN ISO 13485 and document management is an advantage
  • Professional proficiency in both German and English 
  • University degree in a scientific field and/or commercial/technical training in regulatory affairs

Benefits and Perks

  • Being part of an international and well-established company that shows high esteem for engagement, performance, and personal commitment
  • Hybrid working model (2 days per week onsite in their office in Koblach and/or Pforzheim)
  • Open communication and respectful cooperation are defining features of our portfolio company's culture
  • Being part of an instant network within the Project A family

Apply below and become a part of our success story!

Our Commitment to Diversity and Inclusion

Project A is committed to diverse and equal opportunities hiring for all – applicants, candidates, and employees alike. We value humans – with all our glorious multifaceted backgrounds, perspectives, and experiences – and look forward to your application.

Project A is one of Europe's leading venture capital firms, with offices in Berlin and London. Founded in 2012 as an Operational VC, we have backed more than 100 startups across 17 countries and 15 industries, including digital health, Fintech, and mobility. Our dedicated team of 140+ professionals supports our portfolio companies with software engineering, marketing, sales, hiring, and other business-critical services.

Apply now

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About this job

By submitting your application, you consent to the transfer of your data to our portfolio companies. The revocation of consent, also individually, is possible at any time for the future by e-mail to Further information on data processing in the context of applications can be found in the data protection declaration for our application management system.
By submitting your application, you also consent to us processing your above information and documents via our recruiting platform and the service providers Greenhouse and Talentwall in the USA. The USA does not currently offer a level of data protection comparable to that of the EU. It cannot be guaranteed that the data protection rights of EU citizens are fully respected. You can revoke consent and withdraw your application at any time.