The Director, Regulatory Affairs to the head, Quality Assurance & Regulatory Affairs. The Director, Regulatory Affairs 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 levels
• Establishes 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 implementation
• In cooperation with Head, Quality Assurance & Regulatory Affairs, establishes and maintains appropriate procedures for areas of responsibility
• Supports clinical monitoring activities for clinical studies including companion diagnostics
• Prepares and submits clinical device protocols, IRB applications for initial study start, continuing review and study closure
• Submits 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 requirements
• Collaborates with peers from other functional areas and Project Manager
• Serves as contact point for escalation of regulatory or clinical project challenges
• Interacts with FDA, notified body personnel, EU, legal representative and authorized representative, as needed.
• Provides coaching and professional development to team members.
• Incumbent may supervise approximately 5 to 10 team members at the Associate, Specialist or Manager levels.

Required Work Experience:

• Minimum of 8 years of related experience in the in vitro diagnostic or medical device industry working on regulatory submissions
• At least 3 years’ experience leading teams

Preferred Work Experience:

• At least three years of experience working in regulatory affairs roles on CDx projects within the in vitro diagnostic industry.

Physical and Mental Requirements:

• Strong 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 PowerPoint

Knowledge:

US and EU regulatory submission requirements.

Skills:

• Able to effect Quality Improvement through problem solving skills and knowledge of quality tools – required
• Able to lead and drive change – required
• Organization skills--required
• Project and team management skills – required (Quest Management System skills – preferred)
• Analytical and problem-solving skills – required
• Computer skills, including standard business software tools and typing – required
• Able to function in a matrix organization—desired
• Multi-tasking skills—desired
• Flexibility to meet continuously changing priorities and challenges

EDUCATION
Bachelor’s Degree required

LICENSECERTIFICATIONS
Regulatory Affairs Certification (RAC)