Administration PMA/supplement, EU IVDR, PMDA) in collaboration with IVD Regulatory, including labeling alignment. Ensure compliance... regulatory pathways (FDA CDRH, EU IVDR, PMDA). Ability to translate complex scientific and clinical data for cross-functional...
, preferably including regulatory affairs, legal or governmental compliance matters, quality systems, internal auditing, applicable... (GMP) Guidelines – EU GMP MHLW Ministerial Ordinance No. 169, 2004 of the Japanese Pharmaceutical Affairs Law (PAL...
Affairs team, our CMC Associate, and a network of external CDMOs, technical consultants, and specialist contractors across EU...; you are not purely a project manager Solid GMP knowledge and experience of how manufacturing changes interact with regulatory variation...