Quality & Regulatory Affairs Lead – Medical Device Software (SaMDSiMD)
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Job Location:
Monthly Salary:
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
Your mission
As Quality & Regulatory Affairs Lead in our Quality Management team you will take ownership of quality and regulatory strategy across our in-house SaMD product and customer projects where our software is integrated into medical device systems (SiMD) - with a strong focus on interventional navigation and planning.
This is a hands-on leadership role: you will actively contribute to documentation audits and QMS work while building and growing the Quality Management team over time.
Your responsibilities:
- Define strategy for meeting regulatory and quality requirements including MDR and FDA expectations for our in-house and customer software projects
- Provide guidance and support on MDR/FDA-conformant documentation for medical device software including navigation and interventional planning applications
- Maintain and continuously improve our QMS in alignment with ISO 13485
- Develop implement and monitor quality policies procedures and KPIs
- Coordinate internal audits and prepare for external audits
- Monitor regulatory changes and assess their impact on company processes products and customer projects
- Promote a culture of quality and compliance across the organization
- Lead the business development of the Quality Management team (e.g. supporting customer discussions shaping service offerings contributing to proposals and project scoping)
- Build up the Quality Management team over time including mentoring hiring and defining scalable processes
- Stay hands-on in documentation and compliance work especially in the early phase while the team is small
Your profile
- Several years of experience in quality management and regulatory affairs for medical device software (SaMD and/or SiMD)
- Strong knowledge of ISO 13485 MDR and FDA expectations (especially for software and imaging/navigation products with AI components)
- Experience coordinating audits and working with external auditors
- Ability to combine hands-on execution with pragmatic leadership in a growing company environment while managing uncertainty
- Demonstrated ownership of complex initiatives or projects end-to-end
- Strong communication skills and confidence working with engineers leadership and customers
- Motivation to build and grow a quality organization from the ground up
Why us
- Be part of an international dynamic and highly qualified team where you can make a real impact and shape the future together with us
- Enjoy the agility of a start-up combined with the security of an established company
- Receive a competitive salary and a comprehensive benefits package (e.g. bike leasing sports programs Deutschlandticket etc.)
- We celebrate successes together at various team events such as our summer party or Oktoberfest
About us
We are an equal opportunity employer and are committed to creating an inclusive and diverse workplace where everyone feels valued and empowered. We celebrate diversity and welcome applications from people of all backgrounds regardless of race religion color national origin gender gender identity sexual orientation age marital status disability or any other legally protected characteristic. Our goal is to foster a culture of belonging where different perspectives drive innovation and success.
You think you can be a good fit Wed love to hear from you!
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
ImFusion GmbH is a growing company located in Munich, conducting research, development and consulting in advanced medical image computing technologies and computer vision. Our customers include small and large medical device companies as well as academic research labs. We wish to expa ... View more
