• A direct, full - time employment in a large, stable, rapidly growing and yet profitable company.
• Privately owned company with no public debts.
• No ill effects of recent downturn/recession.
• First - rate compensation and benefits package.
• Genuine individual growth potential in this new establishment.
• Open door and highly ethical work culture, with due accountability.
Function Summary :
• Assists the Regulatory Affairs Dept. for ensuring compliance with the requirements set by the EU Medical Device Regulation (MDR 2017/745) and other regulatory bodies.
• Supports the development of internal RA systems and procedures.
• Reports to the European Operations Quality Manager
Main activities :
• Maintains existing and develop new technical files / design dossiers by reviewing and updating the related documentation, to support CE mark of EU products. Ensures that EU regulatory requirements are fulfilled, this includes the Essential Requirement checklist, list of applicable International Standards or guidance documents, risk analysis, communication with the suppliers, test report, and Clinical Evaluation Review Archives the approved documents on the server.
• Involve and develop product validation documentation of active devices.
• Review labelling and marketing materials for compliance with EU regulations; recommends appropriate changes.
• Prepares position papers/statements requested by customers/sales.
• Performs a Regulatory watch to identify and respond to new or revised regulatory requirements including regulatory gap analysis.
• Maintains SOPs related to Medline India RA activity and suggests update of the QMS.
Secondary activities :
• Monitors the local RA activity and provide periodical feedback to his/her manager.
• Maintains regulatory knowledge of European regulations within Medline India in Pune.
• Assist in other Quality and Regulatory areas as necessary to support goals and objectives (Validation, Supplier Change Control, Quality Systems, Quality Audits, etc.).
Qualifications - Duties /
• Qualifications Comp tences requises
• Technical Bachelor s degree (B.E. E&TC / B.E Mech.) with Regulatory knowledge (European Medical device regulation MDR) is added advantage.
• Must have good knowledge & understanding of IEC 60601 - 1 and active devices related standards.
• Familiarity with standard related to Quality Management Systems (ISO 13485).
• Capable in the definition, application and utilization of statistical process control techniques and methodologies.
• Very good written and oral communication in English.
• Ease for reading/creating/modifying documents.
• Good technical report writing skills.
• Able to work with minimal supervision. Self - motivated team player.
Medline is America’s largest provider of medical supplies and solutions, family-led for four generations.
Medline is the largest privately held manufacturer and distributor of healthcare supplies in the United States, providing more than 350,000 pro... Read More