We've got an exciting new opportunity for a Design Control Specialist for combination products.
Location: Basel, Switzerland
Contract Duration: 6 months (01.12.2025 - 30.05.2025)
Reason for Opening:
The team is expanding due to increasing project demands. You will join a growing team of 8, working on multiple drug-device combination projects.
Role Overview:
We are seeking a highly skilled Design Control Specialist with a strong "get things done" mindset to support ongoing and new projects involving drug-device combination products. The successful candidate will bring extensive experience in design control for medical devices and combination products, working independently to create and manage key documentation throughout the product lifecycle.
Responsibilities:
- Document Creation: Write comprehensive design control documents, including Product Requirement Specifications, verification plans, protocols, and reports.
- Requirements Gathering: Collaborate with various internal functions to define user requirements and translate them into design inputs, all consolidated into a single document.
- Planning & Execution: Develop and implement verification plans, set up testing protocols, and work closely with suppliers and Contract Manufacturing Organizations (CMOs) to ensure capabilities meet project requirements.
- Project Involvement: Manage design control activities across multiple projects (2 to 3), specifically focusing on drug-device combination products.
- Compliance & Reporting: Ensure all documentation complies with internal quality standards and is ready for QA approval. Provide regular status updates and reports to the project lead.
Key Deliverables:
- Product requirement specifications
- User requirements documentation
- Verification plans, protocols, and reports
- Contribution to elements of the Technical File and Design History File (DHF)
Profile:
- Experience: Minimum of 5 years in design control for medical devices or combination products, preferably within the pharmaceutical industry.
- Languages: Fluency in English is mandatory. Proficiency in French and/or German is a plus.
- Skills:
- Strong experience in document writing and setting up design control requirements
- Ability to work cross-functionally and gather information from multiple stakeholders
- Solid planning and project management skills, with experience in dealing with external suppliers and CMOs
- Personal Attributes: A proactive, self-driven attitude with a focus on delivering results efficiently.
This is a unique opportunity to play a key role in an expanding team and contribute to impactful projects within the drug-device combination product space.
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