Senior Regulatory Affairs Manager; m​/f​/d

About Sonovum

At Sonovum, you’ll work with an interdisciplinary team that values curiosity, collaboration and ownership — and you’ll contribute to a technology with real clinical impact.

If you’re driven by purpose and excited to grow with a company on the rise, we would love to hear from you.

As a Senior Regulatory Affairs Manager, you will play a key role in implementing our regulatory strategy. You will review regulatory documents for compliance (not only prior to submission) and approve them. Working closely with interdisciplinary teams from Development, Clinical Affairs, and Management, you will play a key role in ensuring that our products are approved quickly, predictably, and cost-effectively, and that regulatory approval is maintained over the long term.

Your Responsibilities:

• You will work with management to develop the regulatory strategy
• You will manage the regulatory documentation for various target markets (particularly Europe and the U.S.), compile the regulatory documentation for the relevant authorities, and assist with the submission process
• You will keep the organization up to date on normative and regulatory requirements
• You will monitor the validity of certificates, evaluate product changes, and take on specific tasks related to the PRRC
• You will be actively involved in the preparation and execution of audits

• Bachelor’s degree in medical technology, engineering, life sciences, or a related field
• At least 5 years of experience in regulatory affairs for active medical devices, ideally with a focus on software
• In-depth knowledge of the MDR as well as experience with the FDA and relevant approval procedures
• In-depth understanding of design control, risk management, and post-market surveillance.
• Experience with software-based or machine learning-based medical devices is a significant advantage.
• Highly structured, analytical, and proactive work style with a strong sense of responsibility and initiative.
• Ability to collaborate across departments in a dynamic, innovation-driven environment.
• Excellent communication skills in English and German.

• A key role with significant responsibility at an innovative medtech company
• The opportunity to actively help shape the regulatory framework for an innovative, machine-learning-based medical device.
• A collaborative, mission-driven work environment with short decision-making paths.
• Opportunities for professional development and ongoing training.
• Flexible work models and a modern work environment.
• Attractive compensation package, including a childcare allowance and Job Bike.
• A corporate culture that values initiative, a sense of responsibility, integrity, and team spirit.