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Professional Regulatory Affairs Manager

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Professional Regulatory Affairs Manager
For our client, an international pharmaceutical company located in Rotkreuz we are accepting applications for the role of Professional Regulatory Affairs Manager.
Your Challenges
The successful candidate will be responsible for the regulatory support of an in-vitro diagnostics, standalone software product. The product in scope shall be transferred into another quality management system and shall become compliant to the new in-vitro diagnostic regulation (IVDR). In addition, the final product dossier shall also support further international registration in key target markets like China or US. Therefor the responsibility includes, development of regulatory strategy for product registrations and the corresponding documentation plans, providing relevant guidance and interpretation for regulations for the project team.

Main responsibilities include (but are not limited to) :
  • Provides support to currently marketed product, manages the regulatory activities of the assigned product within Centralized and professional diagnostics
  • Support the regulatory relevant aspects for the gap assessments of the current product and the related documentation to the regulatory requirements and documentation needed for product registrations.
  • Review, interpretation and reporting of regulatory leadership on product specific regulatory issues that may have impact on the business units, the corporation, or the customer. Assesses and communicates regulatory risks and challenges to project teams (no direct contact with the regulatory authorities)
  • Consultancy and active support of the project teams for interpretation and implementing relevant regulations and guidance.
  • Accomplishes conformity evaluation for existing devices also under the in-vitro diagnostics regulation (IVDR)
  • Planning of deliverables with other regulatory affairs professionals for product
  • registrations, including compilation of corresponding software reports and cybersecurity aspects.
  • Ensures the interface between the team based Rotkreuz and further regulatory affairs teams for product approvals/clearances in the various regions and fulfillment of requirements
  • Works in a cross-functional, multi-site team to ensure alignment and harmonization

Your Skills
  • FH or University degree in a scientific/technical discipline
  • Experience in a regulated environment
  • Significant knowledge of global regulatory processes and proven experience of successful management of product registrations
  • Significant knowledge of regulatory requirements for software products as medical device
  • At least 5 years in-depth industry-related working experience
  • English fluent in written and spoken
  • Good communication skills

Please apply directly online by clicking on "Apply Now".

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