Job Description :
Please find below requirement in Round lake, ILRole : Project Engineer (Regulatory Affairs ) Duration : 12 MonthsMechanical Engineering Background with Medical Domain experience (4+ Years)Regulatory Affairs Background with Medical Domain Experience (2+ Years)MDR Labeling Engineer, Regulatory Affairs Specialist, RegulatoryAffairs Lead, Regulatory Affairs Associate, Labeling Specialist, Label content owner, Labeling Specification Owner, Regulatory Lead.R&D Engineer, Mechanical Engineer with Medical working in a regulated environment (Pharmaceutical, Medical Device or Consumer ProductDomain Knowledge – Labeling /DHF/ MDD/ MDR/ Manufacturing/ Medical Devices/ Change controlEssential Duties and Responsibilities:Review the EU-MDR Labeling Gap Assessment for regulatory compliance and provide review comments to Gap Assessors.Prepare or compile the Regulatory documents according to Regulatory requirements. Review and Approve Labeling Contents, SOP’s & Other related documents.Co-ordinate and Guide the Offshore team members for the Complex Queries.Respond to QA / RA team’s Questions.Responsible for managing the development and release of all Product Labelling deliverables.Responsible for maintaining excellent collaborative relationships with R&D, Product Marketing,Regulatory/Quality and other business functions.Develop project Plans to meet the Regulatory and Business Unit’s deadlines.Lead or Represent Regulatory Affairs in Project teams.