Johnson & Johnson Karrieren
Manager (m/f) Regulatory Affairs and Quality Management – Surgical Process Institute
Requisition ID: 1805691525W
The Surgical Process Institute has led the way in developing digital technologies that improve the standardization of surgical workflows in the operating theatre. SPIs unique digitized and customizable surgery workflow engines enable surgery teams to perform more efficiently, reduce operating time, and deliver better patient outcomes.
As part of its growth strategy, SPI will further develop its proprietary software Surgical Procedure Manager (SPM) and other components, that will be used across different disciplines and workflows before, during and after surgery. Furthermore, SPI has the goal to support the digital strategy of J&J that gives surgeons, patients and other stakeholders access to a global knowledge resource for the improvement of surgical workflows and value-based care. Which means also to support the development of their own standard based on detailed available evidence, process and performance data available.
You will develop a global regulatory strategy for SPI´s software products aligned with the overall business objectives and compliant with JNJ Regulatory Affairs and Quality standards. To successfully execute the regulatory strategy, you develop, implement and maintain the Quality Management System processes.
- 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
- Proven track record of leading regulatory strategies, preparing quality dossiers and delivering on-time approvals
- Proven experience as quality officer establishing or working with quality management systems
- Strong knowledge of global regulations and guidance regarding QMS and Software as a medical Device
- Experience at effectively interacting and negotiating with regulatory agencies
- Excellence in planning and execution; acting result orientated, hands-on mentality
- Strong communication skills – excellent written & spoken English, ability to interact with all management levels of the organization
The well-being and development of our employees are central aspects of our company creed. Individuals who would like to fully realize their potential as part of our international, innovation-driven corporate family and who aspire to have challenging work, will find that our company provides just the right conditions. We consider intensive initial training, further education that is tailored to our employees' work and excellent opportunities for development - both nationally and internationally - to be just as essential as a good work-life balance, attractive compensation and above-average employee benefits. One aspect that distinguishes our company is the large number of measures we have to support our trainees and promote career development in ways that are also compatible with family life.
Surgical Process Institute(7932).