Regulatory Affairs Specialist Ii


Regulatory Affairs Specialist II - Customer Regulatory Support SpecialistThis position supports product compliance activities for plastic labware, general consumer, and medical device products manufactured and distributed globally. The primary responsibilities will involve supporting very detailed product qualification and product compliance requests from customers in highly regulated industries. Additional responsibilities can include supporting cross-functional product development teams, performing risk assessments, coordinating product testing through contract laboratories, drafting procedures, and other tasks as needed.Daily activities include:Interfacing with suppliers, customers, and colleagues via email and phoneLogging and tracking regulatory support requests using Salesforce.comPreparation of product compliance statementsGathering detailed product information and using it to complete customer questionnairesRequesting, reviewing, and cataloging of raw material compliance documentationSuccessful candidate will have the following qualities:Team player with a positive attitudeSelf-driven and able to take on a task with little guidanceFlexibility to manage frequently shifting prioritiesConfidence collaborating with colleagues at all levelsWillingness to take on new responsibilities when neededStrong written communication skills, technical writing experience a plusDemonstrated excellent critical thinking and decision-making skillsContinuous improvement mindsetOrganized with strong focus and attention to detailEducation and Experience requirements:Degree in scientific disciplineProficient using Microsoft Office Software (Word, Excel, Outlook, Teams)Familiarity or experience with any of the following would be a plus:Labware through benchworkBasic knowledge of polymer chemistryUnderstanding of environmental material compliance regulations EU REACH, CA Prop 65, TSCA, etcPharmaceutical and medical device standards and regulations (i.e. USP, ISO , ISO , IVDR, MDR)Writing protocols and proceduresRisk management principlesSAPSalesforce.com
Posted
05/05/2022
Location
Johannesburg, GT, ZA