Remote Regulatory Affairs Manager
pfm medical, inc.
💵 $95k-$113k
📍Remote - United States
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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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