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Consultant(s) (M/F/D)
Either one resource with all qualifications, or two resources.
one focusing on the aspects of a regulatory affairs position (chemical background required) and
one resource as a chemical expert with experience in raw material procurement, supply chain chemicals and qualification of suppliers in the sub-component field
Remote 100% possible
Resource can be from outside of Germany as well
Profile Summary:
Senior consultant with strong experience in the development of detergent and/or high-level disinfection formulations for cleaning and disinfection of medical devices:
The consultant should have a solid background in chemistry, microbiology, pharmaceutical sciences, or a related field, with proven experience supporting technical documentation, quality systems, and compliance with applicable medical device and detergent and disinfectant regulations - Worldwide.
Expertise in formulation design, microbiological efficacy testing, validation, regulatory assessment across multiple countries, and manufacturing scale-up.
Strong project management and cross-functional communication skills are required.
The consultant should also have practical experience in:
High-level disinfection product development
Microbial efficacy testing for relevant organisms and contact times
Compatibility assessment with reusable medical device materials
Stability and shelf-life evaluation
Expertise in medical device and/or biocidal product manufacturing
Manufacturing process development and manufacturing transfer
Evaluation of external production sites for third-party filling and support of the design transfer
Quality system and risk management support
Preparation of technical documentation for EU, Australia (TGA), US (FDA) regulatory submissions and internal reviews
Sourcing of raw materials and supply chain resilience
BPR / ECHA submissions pathways
CLP labeling and packaging
SDS requirements
REACH basis
M&A due diligence, and business case development.
Requirements:
Start: asap
Duration: until end of Feb/March 2027
Capacity: 30h / week
(1 to 2 resources with a total of 30h/week overall. Full-time is estimated at the beginning of the project, but is expected to drop to 20-25 h/week throughout)
Location: 100% remote
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