Lead compliance programs for IESO ensuring adherence to regulations while supporting business and stakeholder engagement in electricity sector.
About the role
- Senior Consultant managing Compliance projects in the medical devices sector with a focus on Quality & Regulatory. Collaborating with a dynamic team in a leading GMP-expert company.
Responsibilities
- Lead Quality & Regulatory compliance consulting projects in the medical device industry, including a focus on medical device software
- Prepare risk analyses and technical documentation
- Implement processes within the quality management system
- Conduct gap analyses to prepare for audits (US FDA & Notified Bodies)
- Provide advice on post-market surveillance in accordance with international regulations
Requirements
- Degree in engineering or natural sciences, or equivalent qualification
- Minimum five years' experience in Quality & Regulatory for medical device products (EU MDR Class IIa+) or in consulting
- Experience with IEC 62304, ISO 14971, and ISO 13485
- Proven expertise implementing regulatory and standard requirements for medical devices
- Solution-oriented analytical and conceptual skills, strong customer focus
- Business-fluent German and English
- Willingness to travel
Benefits
- Dynamic and agile team with the freedom to shape work processes
- Collegial, open company culture with short decision-making paths and a flat hierarchy
- Development opportunities, comprehensive GMP training, mentorship program, and varied QMS/GMP projects
- Flexible work location and hours (flexitime), 30 days' vacation, permanent employment contract
- Benefits such as company pension scheme, capital-forming payments (VWL), and supplementary health insurance
- Choice of company car or BahnCard (train pass), plus bike leasing and company events
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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