Job Description
As a Working Student for Regulatory Affairs & Quality, you play a central role in ensuring the regulatory compliance of our digital health applications.
You support and gain insights in the following areas:
- Approval and listing of our Digital Health Applications (DiGA) and Software as a Medical Device (SaMD).
- Conformity assessment procedures with Notified Bodies as well as preparation and accompaniment of audits by certification bodies.
- Creation and maintenance of technical documentation and relevant regulatory and evidence documents.
- Further development of our compliance system, including harmonization and optimization of requirements from QMS, ISMS, and DPM.
- Monitoring regulatory requirements for digital medical products in Germany and the EU to ensure that our solutions always meet current standards.
- Implementation of data protection regulations, especially regarding GDPR and DiGAV, to comply with legal requirements in digital health.
- Participation in ensuring information security, especially under ISO 27001, supporting the ISMS team in implementing relevant security measures.
Your Profile
We are looking for a dedicated individual with expertise, structure, and passion to advance the quality and regulatory security of our medical products, supporting the Head of Regulatory & Quality Compliance in strategic and operational matters.
- Ongoing studies in medical technology, biomedicine, health/natural sciences, or a comparable field.
- Previous professional experience in regulatory affairs, medical device quality management, data protection, or information security is an advantage.
- Careful and structured working style with a high quality standard.
- Strong communication and teamwork skills to clearly convey complex regulatory requirements and implement them with various stakeholders.
- Excellent language skills: Business fluent German (C2) and fluent English.
- Residence in Berlin or willingness to travel to on-site appointments such as audits, team events, and meetings.
Why us?
- 12 days vacation, hybrid work, MacBook, large monitors at workplace, regular team events & free snacks/drinks.
- Flat hierarchies & hands-on mentality: Small, tightly connected team without bureaucracy – we implement ideas directly and put our egos aside.
- Shaping instead of just working: Your ideas count! We promote innovation and creative approaches to advance digital health.
- Central location & creative environment: Our office is located in the city center – perfectly accessible and full of opportunities for inspiring breaks.
About us
We develop therapeutic software for people with mental illnesses. Our goal is to make psychotherapy more accessible through digital technology and to optimally support the therapy process by combining scientifically based methods with intuitively designed user experiences.
Our apps "Mindable: Panic Disorder and Agoraphobia" and "Mindable: Social Phobia" are prescribed by doctors and therapists as apps on prescription and reimbursed by all German health insurances.