Associate Director Regulatory Affairs IVD
Posted on Sep 25, 2020 by Michael Bailey Associates - Zurich
New opportunity has been created for a new department within a global pharmaceutical company to support regulatory affairs activities for In vitro diagnostic/Companion diagnostics products globally
responsible for global regulatory activities for in vitro diagnostic products associated with clinical development
defining strategy, planning and the preparation of documentation and sections for regulatory submissions from the assigned projects within a global perspective to achieve timely approvals to meet business needs. This includes Study Risk Determinations (SRD), Pre-Submissions, and assisting content development for analytical and clinical validation reports for IVD/Companion Diagnostics (CDx) submissions.
provides regulatory input on cross functional sub teams (Global Regulatory Affairs (GRA) Teams and PV Supply and Technology Solutions (S&TS) Teams).
responsible for leading and ensuring adequate provision of regulatory input to all Health Authority (HA) and Notified Bodies (NBs) interactions on matters in all regions, as agreed with the GRA-CMC-lead and/or GRA-CMC & Devices Leadership Team.
responsible for leading and providing input to internal regulatory business initiatives and cross functional work streams as assigned.
relevant experience in the pharmaceutical industry or a regulatory authority in a Devices capacity, preferably with prior in vitro diagnostics and professional experience in biotech industry
Knowledge in IVD testing or CDx development
Knowledge of combination product, IVD, MDR, 510(k), IMDRF requirements
Demonstrated competence in contributing on cross-functional teams and operating within a Matrix organizational structure
Ability to input the expertise into the global regulatory strategy and global planning, to indemnify the critical issues and share lessons.
Specific skills/competences (Include specific skills and knowledge necessary to meet the objectives of the role)
Effectively works to build relationships and collaborate with people and teams both internal and external to the organization
Ability to overcome obstacles, drive execution and deliver timely results for products in assigned regions and for departmental projects, as assigned
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.