Senior Quality & Regulatory Affairs Manager (m/f/d)
Your Role & Impact
In this senior position, you will own, evolve and safeguard our Quality Management System and contribute directly to the successful certification and commercialization of a breakthrough medical device. You will play a pivotal role in ensuring regulatory compliance and advancing our global market access strategy.
Your key responsibilities include:
- Leading the continuous development, maintenance and compliance of our QMS in accordance with ISO 13485, MDR and relevant FDA regulations.
- Planning, preparing and executing internal and external audits; managing CAPA, NCP and PMS processes end to end.
- Driving the preparation of regulatory submissions for the EU (CE marking), the US (FDA), and additional international markets.
- Ensuring regulatory strategy alignment across R&D, Clinical Affairs, Software/AI development and Executive Management.
- Supporting risk management, design control and clinical documentation activities throughout the product lifecycle.
- Acting as a key advisor on regulatory implications for product development and future market expansion.
Your Experience & Qualifications
- Degree in Medical Engineering, Natural Sciences, Engineering or comparable field.
- Minimum 5 years of professional experience in Quality Management and/or Regulatory Affairs within the medical device industry.
- Proven track record with ISO 13485, MDR, and ideally US FDA regulations (QSR/QMSR).
- Experience with software based or AI enabled medical devices is a strong advantage.
- Solid understanding of design controls, risk management and post market surveillance.
- Highly structured, analytical and proactive working style with strong ownership and accountability.
- Ability to work cross functionally in a fast paced, innovation driven environment.
- Excellent communication skills in English and German.
What We Offer
- A senior, business critical role in a growing MedTech company.
- The opportunity to shape the regulatory and quality foundations of a pioneering AI enabled medical device.
- A collaborative, mission driven environment with short decision paths.
- Professional development and continuous learning opportunities.
- Flexible working arrangements and a modern work environment.
- Competitive compensation package including childcare subsidy and JobBike.
- A culture that values initiative, accountability, integrity and team spirit.
How to Apply
Please send your application including CV to: bewerbung@sonovum.de.
Kindly include your earliest availability and salary expectations.
Sonovum GmbH
Deutscher Platz 4
04103 Leipzig
