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Director, CDx Regulatory Consultant

22 hours, 26 minutes ago
Germany
Full-time
Lead
Business Development
Sales and Business Development
Apply Now
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised
View All Jobs 76

Description

  • Serve as the regulatory subject matter expert for companion diagnostics, including FDA, EU IVDR, and global submission and commercialization pathways.
  • Develop global CDx regulatory strategies, integrated development roadmaps, submission pathways, and milestone-based timelines for client programs.
  • Partner cross-functionally with therapeutic, diagnostic, laboratory, biostatistics, clinical operations, quality, and commercial teams to align development activities and timelines.
  • Advise clients on regulatory requirements for use of assays in clinical trials, including patient selection, risk determinations, IRB considerations, investigational device requirements, and performance study obligations.
  • Prepare and direct global regulatory submissions and supporting documentation, including Q-Submissions, Pre-IDE packages, IDEs, PMAs, PMA supplements, and EU IVDR performance study applications.
  • Lead interactions with FDA, notified bodies, and other regulatory authorities, including meeting preparation, response strategies, minutes, and follow-up communications.
  • Review and direct analytical validation plans, clinical performance study plans, diagnostic protocols, statistical synopses, technical reports, intended use statements, and labeling.
  • Apply quality system, design control, risk management, and post-market regulatory expertise across early development, approval, launch, and lifecycle management.
  • Generate new consulting opportunities and support business development activities such as RFP evaluation, bid defenses, work orders, and client workshops.
  • Manage, mentor, and develop regulatory consulting staff while ensuring quality and regulatory accuracy of client deliverables.

Requirements

  • Bachelor’s degree in life sciences, molecular biology, genetics, pathology, laboratory medicine, regulatory affairs, or a related scientific discipline; equivalent relevant experience may be considered.
  • Minimum 5 years of applicable consulting experience focused on IVD, companion diagnostic, clinical trial assay, or precision medicine regulatory affairs.
  • Minimum 7 years of experience in an in vitro diagnostic, companion diagnostic, pharmaceutical, or regulatory consulting environment.
  • Direct experience working with diagnostic manufacturers/labs and pharmaceutical sponsors on global regulatory and commercialization strategies for companion diagnostics and clinical trial assays.
  • Strong written and verbal communication skills with the ability to translate complex regulatory requirements into practical recommendations.
  • Strong scientific and analytical skills to interpret biomarker, assay validation, clinical performance, and diagnostic clinical trial information.
  • Ability to solve complex regulatory, clinical trial assay, submission, and commercialization challenges with risk-based solutions.
  • Strong leadership, team-building, and interpersonal skills to guide multidisciplinary teams.
  • Master’s degree or higher in life sciences, molecular diagnostics, regulatory affairs, public health, laboratory medicine, pathology, or a related discipline (preferred).
  • RAC certification (preferred).

Benefits

  • Equal Opportunity Employer.
  • Reasonable accommodation available for candidates with disabilities during the application process.
  • Privacy Policy and CA Privacy Notice provided for applicant data handling.
  • Fraud protection and reporting support for recruitment scams.

Interested in this position?

Apply directly on the company website

Apply Now

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