Siemens Healthineers is searching for an experienced Quality and Regulatory professional for the role of Head of Quality & Regulatory – GB&I. This individual will be part of our leadership team and will be responsible for leading all aspects of our Quality and Regulatory approaches. This will ensure that our products and services meet or exceed our customers’ requirements while supporting our business objectives. 
 
The Head of Quality & Regulatory – GB&I’s responsibilities will include regulatory compliance so that our products and services are able to be placed on the market. This will require working closely with all departments and Business Lines to ensure that the requirements of our markets are clearly understood. Our GB&I zone continues to see emerging requirements that are unique, challenging and which need to be understood and articulated across the whole of Healthineers globally. 
 
BREXIT, the Social Value Model (SVM), Environmental, Social and Governance (ESG), Value Based Procurement together with Digital Security are examples of changes that will continually evolve, and which will require Siemens Healthineers to continually improve to remain competitive. These emerging requirements will need to be supported by completion of responses to tender specifications around topics such as cyber security, social responsibility and sustainability. This will require the role holder to collaborate with many departments at all levels within zone and globally. 
 
The ideal candidate will: 
 

• Have experience of leading and guiding a team of experts within the complex regulatory and legislative environment of the UK and Ireland. 
• Have a strong understanding of regulatory procedures and standards, such as ISO 9001, European Medical Device Regulations (EU MDR), UK MDR together with knowledge of our key regulators which will include the MHRA and the HPRA.
• Be required to engage directly with Government Departments, Regulators, Industry Bodies, Certification Bodies, Customers and Suppliers which will require knowledge of local, national, and international requirements.

Head of Quality & Regulatory – GB&I

Mission

The mission for you as the Head of Quality & Regulatory – GB&I will be to represent the Siemens Healthineers Zone in the SHS QT community (QM and RA) and related activities.  You’ll have the responsibility to identify and address zone-wide synergies and operational improvements.  In addition, you’ll act as QT-partner for the Zone Leadership Team and manage QT relevant escalations as needed.  The role reports directly and functionally to the Zone Head (Executive VP, MD for Siemens Healthineers GB&I).

You’ll be responsible for implementing the requirements of Directive 1_D_79 and the SHS requirements (such as but not limited to QRs and ARTDs marked as Directives) in your area of responsibility, as far as applicable.

Role Purpose

You’ll have Zone-wide authority for all applicable SHS QT aspects in coordination with the SHS Zone Head and SHS QT. In this role you’ll lead the development and execution of Siemens Healthineers' Quality and Regulatory in Great Britain and Ireland to ensure compliance with internal and external regulations and support customer requirements.

This position is critical to lead our approaches for our formal management system certifications and for delivering all statutory reporting.

Key Responsibilities

• Lead the GB&I QT Team to deliver regulatory compliance to statutory requirements by national regulators. Significant regulations include UK MDR 2002 (MHRA) and regulations related to Product Related Environmental Protection (PREP; Environment Agency and the Health and Safety Executive).
• Management System Certifications. 
• Directly maintain the following management systems and certificates through management of subject matter experts:
  - ISO9001 Quality
  - ISO22301 Business Continuity
• CE+  Cyber Essentials certification
• Provide support to the following management systems and certificates through management and engagement of QT subject matter experts:
  - ISO14001 Environment (PREP)
  - ISO27001        Information Security (CYSO)
• Technical Regulations and Standards
• Manage our compliance to technical standards that are applicable to our products and services. This includes UK specific requirements, including clinical safety requirements together with product related technical standards.
• NCC (non-conformance cost) 
• Manage our overall approaches for reporting NCCs. To include identification of root causes and subsequent areas for improvement using Healthineers Performance System methodologies (HPS).

Required Skills and Qualifications

• Strong communication skills with the ability to influence at all levels. 
• Strong analytical skills to be able to identify key areas in order to maximise value add and ensuring effective management of risk.
• Leadership experience and the ability to coach and mentor diverse teams
• Experience of working in an international environment.
• Proven experience of working with external stakeholders including customers, suppliers, certification bodies and regulators.
• The ideal candidate will have extensive experience of managing formal certified management systems and be an accomplished auditor.
• The ideal candidate will have Project Management experience and knowledge of improvement techniques (LEAN, HPS, Six Sigma).
• Qualifications or proven extensive experience in Auditing, Business Continuity, Environmental Management, Information/Cyber Security, Quality Management and Regulatory Affairs.