Manager Regulatory Affairs and Quality Management (m/f)

  • Act as Quality Management representative, Safety Officer and Regulatory Responsible Person MDR
  • Lead product risk management team; Identify and assess product risks, opportunities and project issues, and make recommendations to management
  • Establish and maintain a global Quality Management System according ISO 13485 for SPI
  • Implement and monitor Post Market Surveillance processes (CAPA, complaint, adverse event handling) and ensure effective and timely resolution
  • Reporting to management on performance measures for quality improvements and compliance
  • Provide knowledge, support and training to the SPI and relevant teams to operate within Quality Management System and regulatory guidelines, especially with regards to design and development, of software and hardware products
  • Maintain current knowledge of new and emerging regulations guidance and changes in regulatory authority infrastructure to determine potential impacts on organizational processes
  • Correspond with regulatory agencies / notified bodies incl. management of audits, regulatory agency inspections, etc.
  • Planning and conducting internal and external audits
  • Development and successful execution of global regulatory strategies for SPI's software products
  • Manage all aspects regulatory compliance; Prepare and support international product registrations with J&J
  • Support Development Team, consisting currently of 15 people, in creation and maintenance of Technical Files to fulfil global regulatory requirements
  • Identify and assess regulatory risks, opportunities and project issues, and make recommendations to management
  • University degree in Science, Engineering, Medical Technology or equivalent preferred
  • Proven regulatory experience with medical devices, preferably with Software as a medical device

» Job description

Johnson & Johnson Medical Devices
04158 Leipzig