Personal Genome Diagnostics (PGDx) is seeking a Director of Regulatory Affairs to help in the fight against cancer by leading the regulatory submission teams to enable global access to our IVD products. Qualified candidates will have extensive knowledge of domestic and international regulatory requirements.
Key Responsibilities Include:
Lead the submission of documents to FDA, Health Canada, Notified Bodies, and other regulatory agencies. Develop responses to questions or deficiency letters from regulatory agencies.
Direct the submission of documents to CFDA, PMDA, and other Asian markets.
Proactively partner with R&D, Marketing and other groups to confirm the regulatory requirements necessary to place products on international and domestic markets.
Develop and approve appropriate technical documents for regulatory planning in support of project development
Develop and maintain Technical Files for CE marking.
Assess regulatory impact of post-market changes to labeling, design, materials, or manufacturing process.
Represent regulatory affairs on product development teams.
Identify and implement process improvements for regulatory affairs
Review new regulations for implications for the company and recommend strategy to achieve compliance with requirements.
Required 6-8+ years in regulatory affairs within the medical device industry (IVD experience highly preferred).
Experience in ex-US regulatory submissions required.
Minimum Bachelor’s degree in a technical discipline required; Master’s Degree in a technical discipline preferred.
Regulatory Affairs Certification (RAC) preferred.
Must be able to work independently and efficiently to complete multiple projects within deadline.
Internal Number: 32
About Personal Genome Diagnostics
Personal Genome Diagnostics (PGDx) is empowering the fight against cancer by unlocking actionable information from the genome. We are committed to developing a portfolio of regulated tissue-based and liquid biopsy genomic products for laboratories worldwide.
Our expertise in advanced cancer genome analysis ranges from sample preparation and sequencing to data interpretation and analysis. We specialize in high-throughput next-generation sequencing, proprietary algorithms to identify alterations in complex cancer genomes and have developed novel technologies for non-invasive approaches in cancer.
PGDx was founded in 2010 by Luis Diaz and Victor Velculescu to help bring novel diagnostic approaches to patients with cancer. They are internationally recognized leaders in cancer genomics who have extensive experience in the application of innovative genomic technologies for drug development and clinical practice.