Greeting from Intellectt Inc.,
We have and Urgent requirement for APAC Regulatory Affairs Specialist II, please find Below the Job description and let me know your interest. Also please reply with your updated resume.
Please feel free to reach me on 732 680 2967 Ext: 576 or email: ******, for further detail.
Job Description: Role: APAC Regulatory Affairs Specialist II
Location: Alameda, CA- 94502 (Onsite)
Duration: 12 Months
Education: Bachelor's degree
Experience Background (Any): APAC regulatory submissions in Medical Devices or Pharmaceutical industries.
Job Description (Expectation) Responsible for regulatory activities, including product registrations, regulatory impact assessment, etc.Understand country-specific requirements and deliver those to internal stakeholders, including product management, engineering, labeling, etc., for product registration and change planning.Communicate weekly with affiliate RAs in different time zones to catch up on ongoing projects and discuss the issues to solve.Plan and execute the given tasks proactively in a timely manner.Report the status to a manager weekly.Keep the training records up to date to do the tasks.Able to start projects immediately after internal system training.Responsible for implementing and maintaining the effectiveness of the quality system. Supports manufacturing/operations day to day activities for change control. Provides consultation/advice to regulatory specialist for change control and product development. Provides regulatory direction/interpretation on team activities. Interprets and applies regulatory understanding to support of products and teams. Prepares U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide. Handles regulatory activities involved in documentation, labeling, field support. Applies regulatory and technical knowledge to a wide variety of complex work assignments. Maintains and ensures compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports. Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.Other Knowledge of International Standards, such as ISO13485, IEC60601.Knowledge of interactions between RA and other departments to pre/post-market RA activities.Knowledge of APAC country regulations, such as TGA, NMPA, PMDA, MFDS, HSA, TFDA, FDA, MOH, etc.Knowledge of Agile, SharePoint, MS Office, and other software to increase work efficiency.Able to manage time and projects.Able to complete the tasks with minimum supervision.Strict to work 40hrs per week.Experience: 2-5 years regulatory experience and/or 2 years relevant industrial experience typically with a quality, product-development/support, or scientific affairs function
Skills: Knowledge of regulations and standards affecting IVDs and/or biologics
Education: BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.
