R&D - IVD Product Lead in San Juan Capistrano, CA at Quest Diagnostics

Job Description

Look for more than answers.

Patients and Physicians rely on our diagnostic testing, information and services to help them make better healthcare decisions. These are often serious decisions with far-reaching consequences, and require sensitivity, tact and a clear dedication to service. It’s about providing clarity and hope.

As a R&D - IVD Product Lead, you will work for the world leader in the industry, with a career where you will have the opportunity to collaborate and affect change while expanding your leadership skills and technical knowledge. You can make a real impact in a market that is growing and developing.

The R&D - IVD Product Lead will work on-site from our San Juan Capistrano, CA location.

R&D - IVD Product Lead, the role:

The R&D - IVD Product Lead is responsible for creating and leading a joint (Drug-Diagnostic test) planning process to define and implement the strategy to support the launch of diagnostic tests. The role will require managing the launch of in vitro diagnostic assays for FDA submissions.

Job responsibilities:

• Work closely with teams and sites to support commercial launch of IVD products and programs which include systems, assays, instruments, and software.
• Drive new in vitro diagnostic product introduction to completion by advising teams and working with Regulatory Affairs, R&D scientists, IVD resources through the validation and regulatory submission phases of product development.
• Launch assays to comply with the FDA IVD Regulation standards.
• Have a thorough understanding of CLSI guidelines in experiment design, PMA /FDA submissions, engagement with CDRH including lab customer testing needs.
• Provide oversight and approve protocol finalization, documentation, review data and support regulatory (FDA and Ex-US) submission
• Work with consultants, as needed, for successful strategic planning for IVD launch.
• Identify gaps in IVD test launch program and create risk mitigation in collaboration with Pharma Partner.
• Serve as alliance contact point with reagent and instrument manufacturers.
• Serves as the R&D/CDx project lead for the Pharma company
• Build strong internal relationships and collaborations with R&D, Medical Directors, Project Managers, Commercial, Regulatory, Finance and other key functions and teams.

To qualify, the ideal candidate will have the following skills and experience:

• BS or MS in molecular diagnostics, molecular biology, biomedical engineering, or related field. Advanced degree, PhD or MBA a plus
• Minimum of 5 years’ experience in device design control responsibility in the medical device space.
• Strong written and communication skills
• A minimum of 2 years within the companion diagnostic Rx-Dx interface.
• Solid understanding of Class III product development process and global regulatory operational requirements (FDA, EMA, cFDA, etc.)
• Prior experience in In Vitro Diagnostic, clinical laboratory business and/or pharmaceutical industry considered beneficial.
• Self-starter with the ability to work optimally and collaborate with cross-functional teams of R&D, global/regional marketing, regulatory, clinical, quality and operations.

Apply Today

Join us for competitive benefits and development opportunities in a progressive and supportive environment. Help us improve our service, and the experiences of our patients and colleagues. Work with us and together we can be better.

Your Quest career. Seek it out.

All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Quest Diagnostics is an Equal Opportunity Employer: Women / Minorities / Veterans / Disabled / Sexual Orientation / Gender Identity or Citizenship.