Remote Regulatory Affairs Manager

Logo of pfm medical, inc.

pfm medical, inc.

💵 $95k-$113k
📍Remote - United States

Job highlights

Summary

Join us as the Regulatory Affairs Manager, Gene Therapy CDx to apply high-level expertise and in-depth knowledge of regulatory affairs and marketing authorization process. This position will serve as regulatory liaison/legal manufacturer representative with regulatory agencies and pharma partners for Precision diagnostic products.

Requirements

  • BS Degree in Sciences, or equivalent in a Scientific, or similar discipline
  • Minimum of 5+ years of regulatory experience working in a medical device industry, specifically in-vitro diagnostics, preferably with gene therapy and/or CDx
  • Demonstrated knowledge and understanding of global IVD regulations, including but not limited to US, EU, UK, APAC, and MENA regions
  • Strong written and verbal communication skills; highly proficient in spoken and written English is a requirement, proficiency in other languages is a plus
  • Ability to prioritize tasks, deadline-oriented, and good organizational skills
  • Ability to think outside of the box and solve difficult problems with effective solutions
  • Committed attention to detail
  • Strong scientific and analytical skills
  • Strong leadership, team building and interpersonal skills
  • Direct experience working with small and large companies to design global regulatory and commercialization strategies
  • Experience managing staff members and project teams

Responsibilities

  • Lead the preparation of submissions and other documentation as required for global clearance/approval of Precision’s clinical trial assays and IVD-CDx products
  • Serve as a regulatory lead on Precision CDx program development project teams, contributing toward DHF documentation, project plans and participating in meetings with pharma partners
  • Represent Precision in correspondence and meetings with regulatory agencies and Notified Bodies
  • Design strategic approaches to regulatory approvals, clearances, and post-market requirements to support co-development programs and reflect optimal business solutions for pharma partners
  • Review and direct the development of analytical and clinical protocols, technical reports, and other company documents for use in regulatory submissions and in response to queries from regulatory agencies globally
  • Review and edit regulatory communication, submission, timeline, and approval requirement documents for assigned programs and other initiatives
  • Stay abreast of latest regulatory developments on a global scale and communicate to the project teams for impact and possible implementation within Precision’s CDx programs
  • Perform regulatory impact assessment for any changes to clinical trial assays and CDx products for reporting to regulatory agencies
  • Support Precision’s post-market surveillance program

Preferred Qualifications

  • Master’s degree or Ph.D
  • CDx experience
  • Class III IVD and LDT experience

Benefits

  • Discretionary annual bonus
  • Health insurance
  • Retirement savings benefits
  • Life insurance and disability benefits
  • Parental leave
  • Paid time off for sick leave and vacation

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