Regulatory Affairs Manager combination devices

England  ‐ Vor Ort
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Beschreibung

New opportunity has been created for a new department within a global pharmaceutical company to support regulatory affairs activities for combination devices products globally.

Responsibilities:
Management of regulatory activities for marketed and development of digital medical devices (Software as a Medical Device (SaMD) and wearable sensors)
defining the strategy , planning and preparation of digital devices documentation including risk determinations for clinical trial and Real World evidence studies and supporting the development of content for regulatory submissions from the assigned projects within a global perspective to achieve timely approvals to meet business needs. Providing digital regulatory input and leadership for cross functional sub teams (Global Regulatory Affairs (GRA) Teams, PVUs, Information Technology, Clinical Development and operations.
leading and ensuring adequate provision of regulatory input to all Health Authority (HA) and Notified Bodies (NBs) interactions on digital devices matters in all regions, as agreed
leading or providing input to internal regulatory business initiatives and cross functional work streams as assigned.

Requirements:

Already gained experience in the pharmaceutical industry or in a regulatory authority in a Devices capacity,
experience in digital devices and/or mobile apps in the pharmaceutical industry
Knowledge in cross-regulations (e.g.: drug/devices, devices/RTTE/Data privacy.
Knowledge of software development lifecycle processes in a GXP environment and the following regulations:
* 21 CFR 812, Investigational Device Exemptions
* 21 CFR 820 Quality System Regulations
* 21 CFR 50, Protection of Human Subjects
* 21 CFR 312, Investigational New Drug Application
* 21 CFR Part 11 Electronic Records and Signatures
* European Union Medical Devices Regulation
* ISO 14155:2011
* IMDRF Requirements
* Clinical Decision Support Software Draft Guidance for Industry and Food and Drug Administration Staff
* Policy for Device Software Functions and Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff

This is a permanent opportunity, which can be based in Belgium and the UK.

Please send your CV

Michael Bailey International is acting as an Employment Agency in relation to this vacancy.
Start
11/2020
Dauer
permanent
Von
Michael Bailey Associates
Eingestellt
24.09.2020
Projekt-ID:
1972700
Vertragsart
Festanstellung
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