Description

In this role, you will navigate the regulatory landscape for medical devices, ensuring compliance and facilitating product approvals. Your day-to-day responsibilities will include compiling essential documentation, managing audits, and collaborating with various stakeholders to uphold quality standards.

Requirements

• •2-5 years of relevant professional experience
• •Ability to conduct extensive research, in-depth knowledge, and creativity
• •Ability to analyze proposed solutions to complex problems
• •General knowledge of the manufacturing process
• •Quality-conscious, trustworthy, and reliable
• •Willingness to travel to all locations and business contacts
• •Team player
• •Communicative skills
• •Structured and systematic way of working

Tasks

• •Compile registration documents for customers in third countries
• •Prepare free sales certificates and legalizations
• •Gather documentation for Notified Body tests under EU Medical Devices Directive
• •Control and accept technical documentation for conformity assessment
• •Assess compliance with Essential Requirements
• •Prepare and release declarations of conformity
• •Update design guidance procedures and related policies
• •Contribute to risk management and clinical evaluation processes
• •Review and approve regulatory documents for design governance
• •Process change requests and assess their relevance to approvals
• •Serve as a contact for inquiries regarding regulatory standards
• •Interface with RA departments, Notified Body, and authorities
• •Coordinate audits with customers, authorities, and suppliers
• •Handle safety-related complaints with the QM team
• •Participate in maintaining the Quality Management System
• •Engage in the innovation process
• •Ensure compliance with quality, safety, and environmental regulations
• •Make decisions on complex problem solutions
• •Consult and train less experienced personnel
• •Perform technical and process-related leadership duties