Position Summary:

The Regulatory Affairs Manager, Gene Therapy CDx is located in the United States and will be responsible for applying high-level expertise and in-depth knowledge of the regulatory affairs and marketing authorization process.  This position will also serve as regulatory liaison/legal manufacturer representative with regulatory agencies and pharma partners for Precision diagnostic products (e.g., companion diagnostics [CDx] and laboratory developed tests [LDT]).

Essential functions of the job include but are not limited to:

Lead the preparation of submissions and other documentation as required for global clearance/approval of Precision’s clinical trial assays and IVD-CDx products, including the preparation of regulatory submissions, meeting packages, and negotiations with regulatory officials as required 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

Qualifications:

Minimum Required:

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.

Other Required:

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

Preferred:

Master’s degree or Ph.D. CDx experience Class III IVD and LDT experience FDA: PMA, IDE, and Q-Submissions EU IVDR experience: Annex XIV, ethics committee submissions, and CE Mark