Professional Regulatory Affairs Manager

Posted on Jan 15, 2020 by ITech Consult

Luzern, Switzerland
IT
Immediate Start
Annual Salary
Contract/Project

Professional Regulatory Affairs Manager

Role/Project:
For one of our partners are looking for a Professional Regulatory Affairs Manager. The role is a contract position for minimum 12 month in Rotkreuz, Switzerland.

Background:
The Regulatory Affairs team belongs to Roche Solution, Integration and Services (SIS) which is responsible for the optimization and automation of processes. The contractor we are looking for will support the Pre- and post-analytical portfolio (which includes electrical medical devices) with respect to Hardware and Software devices and Software only devices. This mature regulatory role is responsible for the overall development, implementation and coordination of regulatory strategies and activities with focus on hardware products and projects. The Rotkreuz department is responsible for requirements related to platforms developed with internal and external partners.

Main Task:
-Manages the regulatory activities and supports the product care activities of the assigned (existing
and authorized) product portfolio within SIS Workflow and IT Software/Hardware Projects, No Assays
-Assesses and communicates regulatory risks and challenges to project teams and interfaces with the life cycle team (no direct contact with the regulatory authorities)
-Consultancy and active support of the R&D project teams during the development of new products and during the product life cycle
-Accomplishes conformity evaluation for new and existing devices (also under the IVDR)
-Planning of Deliverables with other Regulatory Affairs professionals for product registrations, including compilation of corresponding Software- and Hardware-Reports
-Provides insights into upcoming regulatory changes and trends prior to the issuance of new guidance, standards, laws, or regulations (MDR/IVDR)
-Ensures the interface between client head office 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

Requirements:
-Minimum 5 years or more of experience as Regulatory Affairs Manager in electrical medical devices and/or IVD Instruments
-Experience with Development of Hardware and Software of IVD Instruments preferred
-Mechanical/Electrical Expertise

Nice to Haves:
-Experience in a regulated environment or experience in GxP
-Bachelor or Master with technical or electrical background

Language:
-Fluent in English and German (Nice to have)

Reference
No.: 918896NC
Role: Professional Regulatory Affairs Manager
Domain: Pharma
Location: Lucerne (partly in Kornwestheim, Germany)
Workload: 100% (home office possible)
Travelling: 15% (Stuttgart)
Start: ASAP
Duration: 18.12.2020

Sollte diese Position Ihr Interesse geweckt haben, senden Sie uns bitte Ihr komplettes Dossier via den Link in dieser Anzeige.

Über uns:
ITech Consult ist ein nach ISO 9001:2015 zertifiziertes Schweizer Unternehmen mit Niederlassungen in Deutschland und Irland. ITech Consult ist spezialisiert auf die Vermittlung von IT-Kandidaten für Auftragsarbeiten. Wir wurden 1997 von IT-Profis gegründet und wissen daher, wie wichtig die professionelle Unterstützung bei der Projektsuche und -arbeit ist.

Reference: 828455323

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