Summary

Location: Basel, Switzerland

Role Purpose:
The global Device Compliance, Systems and Operations Team, part of Global Device & Packaging Development (GDPD), needs you to accelerate one of the most diverse and innovative medical device and drug-device combination product portfolios in the pharma industry.

About the Role

Your responsibilities include, but are not limited to:

• Use and maintenance of the Standards database for Medical Devices for Drug Delivery and Drug-Device Combination Products.

• Coordination of impact assessment for changes to standards and regulations and support the technical subject matter experts.
• Maintain & improve the process with the support of the knowledge center.

• External Partner Management: qualification of all service providers and contractors
  • guidance for qualification support in drafting & negotiating quality agreements, perform Quality Risk Assessments

• Organizing exchange meetings with qualified suppliers and technical talks with new potential partners
• Managing special orders
• Supporting in SRM activities
• Aligning within TRD outsourcing strategy
• Communication with internal and external stakeholders
• Leading improvement initiatives
• Collaborating with Procurement
• Coordinating trainings needs

• Confidential Disclosure Agreements: coordinating all activities, acting as a single point of contact for the group, working on a regular basis with Legal.
• Lead Process Management Network meetings: manage and maintain the medical device QMS from business side, track procedure updates together with the authoring teams. Review QMS changes and create actions as needed.
• Defining and maintaining the data ontology for GDPD
• Polarion: Admin and Project Management support - maintaining global libraries.

• Collaborate with project teams to identify areas for improvement of tools and processes used to author Design Control documentation and lead those improvements.
• Consult and actively support the Project teams during the development of new products and the product lifecycle regarding regulatory and design quality assurance aspects.
• Support the project teams in preparing for self-inspections and audits in Basel

• Bachelor's degree essential. Masters or higher degree desirable, e.g. Life Sciences, Engineering, Computer Sciences or similar
• 10+ years of experience in medical devices
• 3+ years of experience in Third Party Management
• Expertise with EU MDR Regulation (EU) 2017/745
• Leading and influencing in global matrix organization; strong communicator & listener, actively reaching out, able to understand and connect across functions
• Senior expert in medical device development and combination product.
• Strong Regulatory and Quality Assurance backgrounds
• English both spoken and written is necessary, German and French a plusExperience with audit and self-inspection supporting roles.