Director, Regulatory Affairs
JOB DESCRIPTION

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
  • Leads the submission of documents to FDA, Health Canada, Notified Bodies, and other regulatory agencies. Develop responses to questions or deficiency letters from regulatory agencies
  • Directs the submission of documents to CFDA, PMDA, and other Asian markets
  • Proactively partners with R&D, Marketing and other groups to confirm the regulatory requirements necessary to place products on international and domestic markets
  • Develops and approves appropriate technical documents for regulatory planning in support of project development
  • Develops and maintains Technical Files for CE marking
  • Assesses regulatory impact of post-market changes to labeling, design, materials, or manufacturing process
  • Represents regulatory affairs on product development teams
  • Identifies and implements process improvements for regulatory affairs
  • Reviews new regulations for implications for the company and recommend strategy to achieve compliance with requirements
REQUIRED EDUCATION AND EXPERIENCE
  • 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
ABOUT PERSONAL GENOME DIAGNOSTICS

Personal Genome Diagnostics (PGDx) empowers 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. PGDx was established by internationally-recognized cancer researchers Dr. Luis Diaz and Dr. Victor Velculescu, who are pioneers in the application of innovative genomic technologies for drug development and clinical practice.

Please submit applications (cover letter and resume) to HR@personalgenome.com Special consideration will be given to internal PGDx employees who apply.

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