Regulatory Site Officer SFD - Software as a Medical Device (SaMD) (m/w/d) – limited contract 24 month

Responsibilities

• Preparation and maintenance of the technical documentation for Software as a Medical Device (SaMD) (up to class IIb) acc. to Medical Device Regulation (MDR) for the registration of Software as a Medical Device in the EU
• Interface with project team and participation at project team meetings
• Coordination and follow up of submission-related regulatory requests
• Ensure regulatory compliance of the software medical devices of the Site Frankfurt Devices (SFD)
• Site interface for submission-related requests relating to Software products of SFD; site contact/interface to regulatory affairs
• Coordination and documentation of regulatory requests in the course of change control management; follow up on related regulatory activities
• Assessment of and decision on regulatory impact on product-related changes; cross-functional communication in complex matrix organisations and support to QA functions for implementation of changes
• Support of coordination and preparation of inspections and audits; participation as subject matter expert in audits/inspections
• Support of creation of the quality handbook/manual

Requirements

Your Education & Experience

• Master degree or equivalent Life Science, Engineering or related scientific discipline, PhD is a plus
• Professional experience in medical device software and preparation of technical documentation (preferably acc. to MDR)
• Expert knowledge and working experience in Quality System Regulations (21CFR820 and ISO13485) for Medical Devices
• Knowledge in IEC62304 Medical Device Software – Software life cycle processes required

Your Language Skills

• Business fluent in both written and spoken English
• Written and oral proficiency in German and/or French is a significant plus

Your Competencies

• Good communication and writing skills
• Application of general office MS programs
• Ability to operate in an international, cross-company and cross-functional environment; creativity and common sense

• Push to go beyond the level we have operated until now
• Put the interest of the organization ahead of own of those of his/her team
• Act in the interest of our patients and customers
• Take action and don’t wait to be told what to do

Our offer

• An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team.
• An attractive, market-oriented salary aligned with your qualifications and including social benefits above average (e.g. company pension plans, health management).
• An individual and well-structured introduction and training of new employees.
• You can create your own career path within Sanofi. Your professional and personal development will be supported purposefully.
• As a globally successful and constantly growing company, Sanofi provides international career paths as well.

Own your future. Make your move!

Diversity und Inklusion sind in den Grundwerten von Sanofi verankert und spiegeln sich in unserer Arbeitsweise wider. Wir respektieren die Vielfalt unserer Belegschaft in Hinsicht auf ihre Herkunft, Erfahrungen und Lebensweisen. Wir erkennen die Bereicherung, die diese Vielfalt birgt, und fördern Inklusion sowie eine Arbeitsumgebung, in der diese Unterschiede sich weiter entwickeln können, zur Stärkung des Lebens unserer Mitarbeiter, Patienten und Kunden.