[Hiring] (Junior) Regulatory Affairs Manager @HelloBetter

Role Description

At HelloBetter, our digital products treat real patients, with depression, burnout, insomnia, chronic pain, and more. We need someone who can hold the line on MDR rigor while explaining its importance to various stakeholders.

• CE marking and ongoing conformity of our software as a medical device with risk class I under MDR.
• Maintain and evolve our Integrated Management System and related Technical Documentation.
• Maintain our ISO 13485 quality management system aligned with international standards.
• Run PMS/PMCF end to end, monitoring incidents and handling reporting obligations.
• Lead internal and external ISO 13485 audits and close all findings.
• Track upcoming regulations and advise teams on compliance.
• Support Research team with fast-track applications and act as a secondary contact for BfArM.
• Utilize AI tools to enhance regulatory operations and documentation processes.

Qualifications

• A completed degree in a relevant field (life sciences, engineering, law, health sciences, or similar).
• 2+ years hands-on experience with MDR, ISO 13485, or DiGAV.
• Fluent in English (written and spoken); German is a strong plus.
• Comfortable working in agile development environments.
• Ability to translate regulations into actionable plans.
• Practical fluency with AI tools for regulatory and QMS work.
• Experience owning an audit or certification process from prep through closure.

Requirements

• Strong project management instincts.
• Sharp analytical and interpretive skills.
• Clear and direct communication skills.
• Problem-solving abilities under ambiguity.

Benefits

• 28 vacation days + compensation for holidays that fall on weekends.
• Tenure-based paid time off - up to three additional days.
• Permanent employment contract.
• Attractive VSOP (Virtual Stock Option Plan) for all employees.
• Tax-deductible pension plan with an above-average employer contribution.
• Free or subsidized fitness memberships.
• Regular team events.
• Additional 10 paid leave days for non-birth parents after the birth or adoption of a child.

Company Description

HelloBetter is a pioneer in digital healthcare, developing evidence-based applications for mental health conditions. Six of our applications are approved as digital health applications in Germany. We focus on making psychological support accessible through innovative technology.