Regulatory Affairs Manager (Medical Devices)
My client, international medical devices company is currently looking for a Regulatory Affairs Manager to take responsibility for worldwide safety and efficacy of dossier registration in medical devices.
Your tasks will be:
•Responsibility for preparation and submission of pre-approval and of post-approval registration dossiers / documentation for pharmaceutical VMPs (emphasis on safety, residue and efficacy sections of the dossier)
•Definition, evaluation and interpretation of regulatory requirements for the development of dossier with a focus on safety, residue and efficacy
•Development and realisation of registration strategies for new and registered products
•Responsibility to manage, coach, develops and motivates staff reporting to this position
•Participation in departmental projects and representation of the company at internal and external functions (e.g. IFAH)
Requirements:
•Degree in Life Science or equivalent background)
• Experience in International Regulatory Affairs for ca. 4 years with min of 2 years line management responsibilities.
• Proven extensive experience in European Regulatory Affairs and excellent knowledge of regulatory legislation and
• Established understanding of medical devices industry
•Ability to work to firm deadlines, in an independent result-orientated manner as well as in a team
•Thoroughness, commitment, fine attention to details and persistence
•Excellent written and spoken English
•Good communication, negotiation and organisational skills
My client is based in Austria. This is a permanent role and candidates from the whole of Europe are welcome to apply. German language is not essential.


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