Regulatory and Start Up Specialist - Nordics

Job OverviewPerform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.

Opportunity within FSP for a Regulatory and Start Up Specialist in Nordics with experience in EC / RA submissions and someone who possess strong understanding of local regulatory requirements. Language requirements are fluency in Swedish, Finnish, DanishBoth devices experience and contract negotiations would be beneficial.

Essential FunctionsUnder general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.

Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members. Prepare 1 …