Dir, Regulatory Affairs

Quest Diagnostics

$120K — $160K *

clock 2 months ago

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8 - 10 years of experience

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Job Description

Overview

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.

Responsibilities

  • 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.


Qualifications

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)

EEO

Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets
Celera is a healthcare business that uses knowledge of human variability to provide new tests and services to personalize disease management. Their Products business develops and manufactures molecular diagnostic products that are used by hospitals and other clinical laboratories to detect, characterize, monitor and select treatment for disease. They have a distribution agreement with Abbott, through which they develop and commercialize a wide range of molecular diagnostic products, with Abbott serving as the distribution partner.



Quest Diagnostics Careers



Joining Quest Diagnostics means becoming part of a team committed to everyday excellence and innovation in health. As a leading provider of diagnostic insights, Quest Diagnostics offers unparalleled job opportunities in the medical and scientific sectors, making it an ideal place for professionals seeking growth and development in their careers.

Work You’ll Do



At Quest Diagnostics, you will contribute to a culture that values integrity and accountability, where your work significantly impacts patient health and community well-being. Our diverse team of professionals leverages cutting-edge technology and data to lead advancements in diagnostics and healthcare solutions.

Explore Career Opportunities



Whether you're looking for a position in the lab, a leadership role, or a support function, Quest Diagnostics provides a breadth of opportunities. Our commitment to professional growth includes robust training programs and opportunities for advancement, ensuring that every employee can thrive professionally.

Innovate with Us



Join a team where innovation is at the heart of what we do. At Quest Diagnostics, your skills in science, technology, and beyond can help drive transformation in healthcare services. Our collaborative environment encourages creativity and out-of-the-box thinking to improve patient outcomes and streamline processes.

Internship and Employment Opportunities



Start your career path with Quest Diagnostics through our internship programs or full-time employment opportunities. We are committed to hiring talented individuals who are passionate about building a rewarding career in healthcare. Our internships provide a solid foundation in industry-specific skills and networking opportunities, setting the stage for a successful career.

Benefits and Culture



Quest Diagnostics is dedicated to fostering a workplace where diversity and inclusion are embedded in our DNA. From competitive benefits and wellness programs to diversity training and flexible work arrangements, we ensure our employees have what they need to succeed both professionally and personally.

Leadership and Development



We believe in nurturing leadership skills at every level of the organization. Quest Diagnostics offers various leadership programs designed to help you grow as an influential professional. With continuous learning and development, you can expand your expertise and take on new challenges.

Join Our Team



Search open positions that match your skills and interests. At Quest Diagnostics, we look for driven, curious, and innovative team players who are ready to make a difference. Explore the many facets of our business, from scientific research to client services, and find where you can make your mark.

Stay Connected



Keep up to date with career tips, industry insights, and the latest innovations at Quest Diagnostics. Our careers blog offers valuable information to help you navigate your professional journey effectively.

Job Alert Emails



Customize your subscription to receive job alerts and insider tips tailored to your preferences. Discover the exciting and rewarding career opportunities waiting for you at Quest Diagnostics.

At Quest Diagnostics, every role has an impact. Embark on your career journey with us and transform the landscape of healthcare through the power of insight.
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Total value of jobs:
$507,949,278
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Total Jobs:
665
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Average Pay:
$160,489
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% Masters:
37%

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