Beschreibung

As a Senior Expert - Device Project Leader, you will guide cross-functional teams in managing the drug-device combination product portfolio, ensuring compliance and supporting regulatory processes while driving project success.

Anforderungen

• •Master or PhD in natural science, engineering, pharmaceutical field, or equivalent
• •Minimum 2-4 years of experience in the pharmaceutical industry, preferably in drug-device combination product technical development
• •Ability to work and lead a cross-functional team in a matrix environment
• •Proven knowledge and track record in project and program planning and execution
• •Understanding and awareness of regulatory guidelines for drug-device combination products, including relevant ISOs and cGMP
• •Collaborative spirit, self-driven attitude, high level of learning agility, good listening skills, strategic thinker
• •Fluency in English (oral and writing), German is beneficial

Aufgaben

• •Represent GDPD in CMC sub-teams
• •Lead device-related discussions and secure project strategy endorsements
• •Act as the single point of contact for device and packaging issues
• •Plan and manage project resources, schedules, and budgets
• •Assess and negotiate internal and external resource needs
• •Establish and maintain a high-quality Design History File
• •Ensure compliance with internal processes and regulations
• •Contribute to process and delivery technology improvements
• •Evaluate device technology for different project phases
• •Support internal and external audits on packaging and medical devices
• •Assist in preparing regulatory dossiers for medical device registration
• •Respond to health authority queries

Benefits