Job Code : ABBVJP00023163 Job Title: Regulatory Labeling Specialist (Change Request) Location: Dublin,CA 94568 Duration: 6 Months Job Description: US-CA-Dublin 6 month contract Looking for candidates with regulatory labeling and change process/request exp if someone has labeling and change request/process exp then degree in any field would be considered Labeling design exp More years of exp will also be considered. SolidWorks or Creo exp is needed. Engineering change exp Label changes exp Supporting label changes around regulatory space Managing projects and project schedule Coordinating tasks Medical device label exp is a plus. Change management around engineering change of things (change process or change request) Electromechanical based mechanical device exp would be a plus. 5 yrs.
exp is a must have. Less than 5 yrs.
exp will not be considered. Engineering degree would be a plus. 5 yrs.
exp would be needed even with a master's degree. Description The Contractor Engineer Combination Products works with technical supervision on project teams in support of combination products and medical devices. Activities include contributing to product design documentation and conducting laboratory studies of product performance in support of product development, manufacturing transfers and investigations, supplier driven design changes, and product enhancements. Products are intended for drug delivery and include plastic disposable and implantable products, and electromechanical devices with integrated software. Work is conducted in compliance with device design controls (FDA 21CFR820.30 and/or ISO 13485) as applicable. Primary Function / Primary Goals / Objectives: Conduct independent laboratory work and data analysis Design and build laboratory test fixtures Troubleshoot experiments and instrumentation Learn and understand new experimental techniques Demonstrate skill in multiple techniques and modify protocols as required Place data in proper scientific context by consulting and citing relevant literature Demonstrate technical proficiency in medical device performance characterization Understand and adhere to corporate standards regarding code of conduct, safety, medical device design controls and GxP compliance. Level of Expertise: Able to work in a regulated environment Familiar with lab environment and safety practices. Able to independently develop and validate test methods with emphasis on mechanical testing Applies basic computer skills in support of data analysis Proficient in mechanical design using Solidworks and generating specification documents and drawings Applies technical writing skills to produce technical reports and documents Level of Leadership Activities: Works under direction of senior staff Summarizes and presents results of projects to project teams Independently executes laboratory studies and proposes improvements to laboratory capabilities and processes Level of Interpersonal Skill: Works in team environment Collaborates with others on design and data analysis Able to present work to small groups Education: Bachelors Degree or equivalent education in Biomedical, Mechanical, Chemical Engineering, Materials Science or related field with 5+ years of experience Masters Degree or equivalent education in Biomedical.
Mechanical, Chemical Engineering, Materials Science or related field with 3+ years experience Skill Year of experience How it was used?
DESIGN DOCUMENTATION
ISO 13485
MATERIALS SCIENCE
Drug Delivery
Manufacturing
DATA ANALYSIS