Senior Consultant Regulatory Affairs / Quality Management Medical Devices
You're driven by customer success in bringing regulated products to the market. As a Senior Consultant, you are a subject matter expert who empowers interdisciplinary teams. As an inspiring leader, you provide clarity on regulatory requirements, and you help your peers and customers to take pragmatic decisions. Together with your colleagues, you ensure the smooth implementation and submission of customer projects.
As Senior Consultant in the team Medtech & Pharma, you will be responsible for various topics:
- Consulting our customers in quality management and regulatory affairs and helping our internal teams to run their projects in a compliant manner.
- Providing training and support in medical device regulations, quality assurance, compliance, and strategic advisory to medical device or pharmaceutical manufacturers.
- You contribute to building technical documentation and design dossiers, which our customers will use for their CE marking or FDA approval processes.
- Review and development of technical files and quality management systems, help improve our customers’ compliance.
- These areas can vary over time, according to personal preference or aptitude. We will shape your individual career path together – and we are looking forward to it!
- You have a t least 7 to 10 years overall working experience in the field of medical devices through various positions in industry, consultancy or Notified Body, in either manufacturing, R&D, quality or regulatory roles (e.g. Manager Regulatory Affairs & Quality Assurance).
- A technical degree from a renowned university (mechanical engineering, physics, biomedical engineering, software engineering, etc.), as well as fluent German and English skills are required for this position.
- You have spent more than five years in software and/or hardware engineering, preferably in the field of Software as a Medical Device (SaMD), Digital Health Platforms & Smart Connected Medical Devices.
- Profound knowledge of the relevant regulations (CE, FDA, MDR, IVDR, ISO 13495, IEC 62304, IEC 60601, ISO14971, etc.) and the passion to continuously expand this wealth of know-how is what we expect from you.
- With your quick grasp, strong communication skills and understanding of business processes, you understand complex customer problems and can also respond to the needs of employees.
- Even in demanding multitasking situations you do not lose your high-quality standards.
- Unique culture - we communicate openly with each other, assess ourselves honestly and enjoy working in a team.
- Further development – we invest 10% of our turnover in the development of our employees. We help you grow through continuous, high-quality training.
- Knowledge exchange - we have an interdisciplinary approach, culture of knowledge sharing and learning from each other.
- International topic groups – we exchange experience, knowledge and support each other in our further development within our internal communities.
- Great workplace – we offer a culture of trust, encourage you to think outside the box and to share your ideas.