Lead a team of engineers and specialists through device combination product projects creating compliant design history files towards regulator dossiers for agency submission 5 yrs; coordinate and guide a team of regulatory labelling specialists to produce instruction for use documents for the safe use of drug delivery devices 3 yrs; negotiate with global regulatory agencies and persuade the agencies to accept data packages towards drug device approval 5 yrs; monitor and assess regulatory guidelines and standards for the successful and compliant development of device drug combination product modalities 3 yrs. 15 travel required.
Categories: eb3
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