The Director, Regulatory Affairs to the head US Regulatory Affairs for assigned client. The Director, Regulatory Affairs is responsible for successful completion of complex regulatory projects such as: pre-submissions, IDE submissions to FDA, IRB submissions, supplements, annual reports, and premarket authorization 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 (i.e., IDE supplements, amendments etc.)
• 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 and IRB
• Provides coaching and professional development to team members.

Required Work Experience:

Minimum of 8 years of related experience in the in vitro diagnostic, medical device industry, or pharmaceuticals 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 regulatory submission requirements.

Skills:

Able to effect process 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

LICENSECERTIFICATIONS

Regulatory Affairs Certification (RAC)

Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets