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We are looking for Clinical Affairs Managers within the cutting edge Medical Device industry, based in Bern Medical Device/Clinical Affairs Manager Tasks Planning, execution, and management of clinical studies from A to Z Preparation and review of all types of clinical study documents Preparation...

• Plan and perform GMP/GDP Audits at Contract Manufacturing Organizations (CMOs) or Suppliers
• Prepare audit findings & reports and discuss potential impact on business

• Own EU regulatory strategy for assigned programs from First-in-Human through pivotal development and marketing authorization.
• Serve as primary EU regulatory contact for cross-functional teams and provide clear, actionable regulatory guidance while ensuring compliance with regulatory requirements

• Develop and execute regulatory strategies for products and services
• Provide regulatory expertise for complex or unique issues and challenges regarding registration and compliance activities.

• Ensuring compliance with applicable medical device software regulations and standards, including ISO 13485, ISO 14971, IEC 62304, IEC 62366 and IVDR
• Defining, maintaining, and governing software-related quality policies, procedures, SOPs, templates and lifecycle frameworks

In the role as _Global Head of Regulatory Affairs_, you lead a global organization of approximately 80 regulatory professionals across CMC Regulatory and Regulatory Affairs and drive regulatory strategies for the established product portfolio, focusing on product integration, lifecycle management,...

Providing strategic regulatory guidance developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and managing lifecycle regulatory activities in alignment with the Therapeutic Area Lead under the direction of the Senior...