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Director, Regulatory Affairs
3 months ago
Overview:
Responsibilities:
- Manages team of regulatory and clinical professionals at the Specialist or Manager levels
- Establishes and executes regulatory and clinical strategies, in cooperation with crossfunctional 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
- Submits Technical Files, presubs, 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.
Qualifications:
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
- Project and team management skills required (Quest Management System skills preferred)
- Analytical and problemsolving skills required
- Computer skills, including standard business software tools and typing required
- Able to function in a matrix organization—desired
- Multitasking skills—desired
- Flexibility to meet continuously changing priorities and challenges
EDUCATION
Bachelor's Degree required
LICENSECERTIFICATIONS
Regulatory Affairs Certification (RAC)
EEO:
Quest Diagnostics is an equal employment opportunity employer.
Our policy is to recruit, hire and promote qualified individuals without regard to race, color, religion, sex, age, national origin, disability, veteran status, sexual orientation, gender identity, or any other status protected by state or local law.
Quest Diagnostics observes minimum age requirements established by federal, state and/or local laws, and will ask an applicant for verification when deemed necessary.
