The Director, Regulatory Affairs for EMEA is responsible for successful completion of complex regulatory projects, including pre-submissions and IDE submissions to FDA, IRB submissions, Ethics Committee submissions, EU Annex XIV submissions and as well as premarket authorization applications, including PMAs and EU Technical Documentation submissions to the notified body and other ROW regulatory applications. 

Manages team of regulatory and clinical professionals at the Specialist or Manager levelsEstablishes and executes regulatory and clinical strategies, in cooperation with cross-functional project teams.Provides guidance to staff on identification of regulatory and clinical requirements and supports staff with the effective implementationIn cooperation with Head, Quality Assurance & Regulatory Affairs, establishes and maintains appropriate procedures for areas of responsibilitySupports clinical monitoring activities for clinical studies including companion diagnosticsPrepares and submits clinical device protocols, IRB applications for initial study start, continuing review and study closureSubmits Technical Files, pre-subs, IDEs, FDA and EU related activities (i.e., IDE supplements, amendments etc.)Leads the IVDR activities for Provisional Transitions for procedures and IVDR requirementsCollaborates with peers from other functional areas and Project ManagerServes as contact point for escalation of regulatory or clinical project challengesInteracts with FDA, notified body personnel, EU, legal representative and authorized representative, as needed.Provides coaching and professional development to team membersIncumbent may supervise approximately 5 to 10 team members at the Associate, Specialist or Manager levels
Minimum of 8 years of related experience in the in vitro diagnostic or medical device industry working on regulatory submissionsAt least 3 years’ experience leading teamsBachelor's degree is requiredRegulatory Affairs Certification (RAC) requiredAt least three years of experience working in regulatory affairs roles on CDx projects within the in vitro diagnostic industryStrong verbal and written communication skills.Demonstrated success in motivating team members to reach objectives.Strong influences skills and excellent interpersonal skills.Demonstrated PC experience with SPCXL, MS Word, Excel and PowerPointKnowledge of US and EU regulatory submission requirements

Skills:

Able to effect Quality Improvement through problem solving skills and knowledge of quality tools – requiredAble to lead and drive change – requiredOrganization skills--requiredProject and team management skills – required (Quest Management System skills – preferred)Analytical and problem-solving skills – requiredComputer skills, including standard business software tools and typing – requiredAble to function in a matrix organization—desiredMulti-tasking skills—desiredFlexibility to meet continuously changing priorities and challenges