Research Scientist I

Act as Product Design Owner (PDO)/PDO Support within its product family and technical expert for projects in development and lifecycle management activities within R&D Kidney Care Solutions Development Organize, plan and execute sustaining activities in compliance with current QA/ environmental/ regulations and standards Provide technical leadership, mentor and guide the change owners and Project Leads within its product family in order to get tasks accomplished according to plans, milestones and business needs Review and approve Design Control documentation for projects in development and sustaining activities Responsible and accountable for the design history files of a given product family Establish, maintain and update technical specifications describing product appearance, characteristics and functions, and associated verification and validation documents Organize, plan and follow the execution of product changes, supplier changes and labelling tasks related to life cycle management projects Support worldwide product registration and launch following international/regional/national regulations; provide technical support to authoritiesquestions Provide technical leadership for products/process/cost improvements related to life cycle management projects Provide resource estimation and forecast Ensure good internal and cross-functional communication at a global front and regular status update of projects Qualifications Masters in chemistry or M Pharm with at least 14 years of relevant experience or Ph D in relevant sciences discipline with at least 7 years of relevant experience Excellent English verbal and written communication skills Exposure to medical devices and drug products Good knowledge of product development stages and life cycle management: development, stability, clinical, registration, process transfer, production, suppliers, customer service Good knowledge of Design Control documentation and process Demonstrated project/program leadership in drug/pharmaceutical products Exposure to Product Risk Management for medical devices and drug products Working knowledge of international/regional/national regulations and standards Experience in project management and stakeholder management at a global front Must be able to able to carry out strategy and vision set by upper management and be able to communicate the vision to more junior associates Ability to work independently Skills Excellent English verbal and written communication skills Self-directed, resourceful, and able to work on multiple projects and priorities Strong organization, attention to detail, and documentation skills Very adept at grasping and solving complex problems using root-cause analysis techniques Ability to objectively identify technical solutions and make sound decisions Equal Employment Opportunity Vantive is an equal opportunity employer Vantive evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other legally protected characteristic Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information To learn how you can protect yourself, review our Recruitment Fraud Notice