Regulatory Specialist

Spectraforce Technologies
United States, California, Alameda
Nov 19, 2024
Title: Regulatory Specialist II Duration: 1 year with the possibility of extension Location: Alameda CA 94502 Experience Background (Any): APAC regulatory submissions in Medical Devices or Pharmaceutical industries. 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: Bachelors degree Job Description: 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. 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. 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. 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. CPRA: The Company is committed to complying with the California Privacy Rights Act ("CPRA") effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAhr@spectraforce.com.