Professional Regulatory Affairs Manager
Posted on Sep 1, 2020 by ITech Consult
Professional Regulatory Affairs Manager - GxP/IVD/English/software/medical device
For our partner a big pharmaceutical company in Rotkreuz we are looking for a highly motivated and qualified Professional Regulatory Affairs Manager
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 the US. Therefore the responsibility includes the development of a regulatory strategy for product registrations and the corresponding documentation plans, providing relevant guidance and interpretation for regulations for the project team.
- Provides support to a 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 an 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 the compilation of corresponding software reports and cybersecurity aspects.
- Ensures the interface between the Roche 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
- FH or University degree in a scientific/technical discipline
- Significant knowledge of global regulatory processes and proven experience of successful management of regulatory procedures
- At least 5 years in-depth industry-related working experience
- English fluent in written and spoken
- Experiences with software as a medical device are beneficial
- Experience in a regulated environment or experience in GxP
Nice to Haves:
Reference No.: 919595 ADRole: Professional Regulatory Affairs Manager
Industry: Pharma Location: Rotkreuz Workload: 100% Start: 16.09.2020End date: until 31.08.2021, with possible extension
Should you find yourself suitable for this position then please send us your complete CV using the link in this advert.
ITech Consult is a certified ISO 9001:2015 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.