Description
Professional Regulatory Affairs Manager - GxP/IVD/english /software/medical deviceProject / Role:
For our partner a big pharmaceutical company in Rotkreuz we are looking for a highly motivated and qualified Professional Regulatory Affairs Manager
Background:
Responsible for managing all facets of regulatory support to market products. This includes development of regulatory strategies, submissions, reviewing labeling and promotional materials, providing guidance and consultation for regulations, interacting with managing projects to support registrations, main focus implementation of implementation of the new EU In-vitro-diagnostics Regulation (IVDR).
Main Tasks:
? Manages the regulatory activities and supports the product care activities of the assigned (existing and authorized) product portfolio within Centralized and professional diagnostics.
? Assesses and communicates regulatory risks and challenges to project teams (no direct contact with the regulatory authorities)
? Consultancy and active support of the R&D project teams during the product lifecycle
? 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
? Ensures the interface between Roche (Rotkreuz) and 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
Skills / Requirements:
? 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 medical device are beneficial
? Experience in a regulated environment or experience in GxP
Nice to Haves
? German
? Quality Management experience for medical devices / In-vitro diagnostics
? Good communication skills
Reference No.: 919595SGR
Role: Professional Regulatory Affairs Manager
Industry: Pharma
Location: Rotkreuz
Workload: 100%
Start: 16.09.2020
Duration: 4++
Should you find yourself suitable for this position then please send us your complete CV using the link in this advert. If the position is not a perfect match and you wish to receive other opportunities directly, you can send us your CV anyway via this advert or to jobs[at]itcag[dot]com.
Contact us for further information regarding our company, our positions or our attractive payroll-only-program: .
About us:
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.