Job Description

Essential Duties and Responsibilities. Develop strategies to effectively apply a risk-based scientific approach within a regulatory framework to support trace analysis projects and change control activities. Collaborate with a multidisciplinary team of subject matter experts (e.g. E&L, Materials, Biocompatibility, and Toxicology) to develop trace analysis strategies that align to regulatory requirements for medical devices and drug products. Participate in E&L change control impact assessments when applicable to trace analysis and work with cross functional team members (design owners, E&L SMEs, materials, preclinical, etc.) to determine a comprehensive testing strategy through writing impact assessments, gap assessments, technical rationales and documents related to such change controls. Maintain and apply current knowledge of relevant Quality System Regulations and other regulatory requirements related to chemical characterization product development, design and safety. Interact across functions (Design Owning Organization, Project Management Organization, Regulatory Affairs, Preclinical, etc.) to understand products and therapies, as well as business, technical, and regulatory requirements to meet project needs. Qualifications . -Demonstrated experience in applying trace analysis methods and tools as part of R&D -Knowledge of regulatory expectations related to trace analysis for drugs and devices. -Performing change control in a GMP environment. -Experience in working in global cross-functional teams for trace analysis projects -Independent problem solver who can use a methodical approach to develop solutions and make recommendations. Education and/or Experience. Bachelor s degree in scientific discipline (Analytical or Organic chemistry preferred) with a minimum 14 years of experience, or MS with a minimum 7 years of experience or PhD with a minimum 3 years of relevant experience. Recruitment Fraud Notice