Senior Expert - Device Project Leader - Combination Product Portfolio (80-100%)

Your responsibilities include but are not limited to: Represent GDPD in CMC sub-teams, leading device-related discussions and securing endorsement for project strategy or changes. Lead cross-functional project teams, acting as a single point of contact (SPOC) for all device and packaging related issues. Plan, manage, and control project resources, schedules, and budgets. Assess and negotiate internal & external resource needs on an ongoing basis. Establish and maintain a high-quality if necessary adequate documentation up to Design History File, in case of the product is a combination product for developments and LCM projects until transfer to manufacturing sites. Ensure compliance with internal process requirements and current regulations, including Design Control, CMC, FDA combination product regulations and ISO requirements. Contribute to the improvement of process and delivery technology approaches. Evaluate suitable device technology to support different project phases. Support internal and external audits on packaging and medical device related matters. Assist teams in regulatory dossiers preparation, including documents for medical device/combination product registration and in responding to health authority queries.