Quality has always been at the heart of everything we do. As Senior Quality Manager you will join our QM and Regulatory Affairs team. You will ensure that measures are in place for a high level of consistency of the regulatory processes at smartpatient. It will be your job to maintain our agile approach while ensuring our medical device related processes to comply with ISO 13485 and other quality standards. As we are often pioneers in our field, we need a pragmatic person who is eager to expand into new fields of products and services. You will work closely with product development as well as our account leads to plan and shape our future products.
You will be part of our vibrant and highly international Munich office with frequent team events and free drinks and fruit. Your will receive a competitive compensation package and can work on equipment of your choice. Last not least, your work will make a difference in the life of millions of patients.
Your tasks will include...
- Managing / refining our ISO 13485-compliant QMS and RMS
- Safeguarding and supporting compliance along product development process and tools (e.g. Jira)
- Owning communications with competent authorities in and beyond the EU for our medical devices
- Advising on regulatory aspects in our work with industry partners, e.g. around smart device connectivity
- Implementing internal improvement process including internal audit, CAPA or non-conformity management
- Continuously looking for innovative approaches that best-possible bring together quality management and agile product development
You should bring...
- Professional experience with current EU and FDA medical device regulations and guidelines
- Professional experience with ISO standards for quality (IEC 62304, AAMI TIR45), risk management (ISO 14971)
- Experience in audits by notified bodies and/or FDA
- Experience in 'software-as-medical-device'
- Experience in regulatory approvals of medical devices / CE marking
- Experience in authoring lean process descriptions that align with business importance and formal necessities
- Experience in optimizing existing processes to work for multiple regulatory jurisdictions and at the same time minimizing impact on daily work as far as possible
- Excellent oral and written English
- A passion for using innovative tools
- A passion for learning and working in a rapidly evolving environment