MDR Archives

Regulatory Affairs Associate II – Temporary (J1908) – FILLED

Location: St. Paul, MN Duration: 12 months Position Responsibilities Prepares robust regulatory applications or technical file documentation to achieve departmental and organizational objectives and support EU MDR transition activities. Creates, reviews and approves engineering change orders. May act or assist as a regulatory representative on core product development teams, communicates regulatory requirements and impact of [...]

Labeling Specialist/Technical Writer – Temporary (J1907) – FILLED

Location: Maple Grove, MN Duration: 6-12 months Position Responsibilities Ensures compliance to internal and external labeling requirements, specifically for EU MDR Completes artwork redlines (labels, Directions for Use- DFU/IFU, and cartons) Updates label template specifications Updates labels using Global Labeling System (Prysm ID software) Aids internal labeling project specialist in labeling requirements gap assessment Gathers [...]