Hubertus Stockmann

Establishing the Gobal Third Party Due Diligence Organization - Conducting Third Party Due Diligence on Regional Level followed by final approval via Subject Matter Expert Review - Develop risk-based Due Diligence methods, tools, systems and procedures - Build up, lead, train and coach an expert team of > 10 FTE and heading an external team of ~ 30 FTE - Conducting Due Diligence under Monitorship requirements and providing reports, initiating remedial measure subject to the assessment by the DOJ / SEC

Key Responsibilities - Development and implementation of a compliance program, policies, procedures and training for EMEA region - Provide commercially focused support and strategic guidance to EMEA heads of sales and operations - Identify, train and leverage compliance champions - Third Party Compliance, policies and oversight structures to identify and mitigate risks - Global Data Protection Regulation, serve as the Group DPO, risk assessment, recommendation, implementation and training

• Implementation and maintenance of Group Compliance Frameworks • Consistency with Global and regional Compliance Program • Develop and rollout training plans and conduct Trainings • Advise the Business and act as primary Compliance point of contact and coordinator • Responsible for risk assessments and support investigation

Responsibility for the development and implementation of a Compliance framework in the Pharma Division on a global level • Compliance program, policies and processes, training, information and communication, Compliance reporting and monitoring • Responsibility for Compliance with applicable laws, regulations and codes • Influence on the strategic decisions of the Pharma division • Conduct complex Compliance projects • Chairmen of the Healthcare Compliance Committee

Global responsibility for the departments of Ethics & Compliance, audit, CAPA, QMS and EHS • Compliance strategy & objectives • Corporate compliance program, -organization and –committee • Global helpline incl. triage & investigations and measures • CoC, FCPA, UK Bribery Act, cartel agreements, ABAC, fair competition, Advamed, Eucomed, EFPIA, Sunshine Act • B2B and B2C, OTC, social media • FDA Readiness

• Compliance Program (policies, procedures, trainings, whistle blowing) • Advising the commercial departments related to areas of high compliance risk (e.g. off label, financial interactions, FMV, grants & donations) • Company contract management in compliance with due diligence requirements and risk assessment aspects • Global Anti-Bribery & Fraud policies (e.g. FCPA, UK Bribery Act 2010) • Chief Privacy Officer incl. Safe Harbor • Company representative with trade associations (Eucomed)

• Oversight, monitoring and implementation of the compliance program including European compliance reviews and audits • Development and execution of trainings related to European regulations • Development and implementation of a contract process and a grants & donation process for Europe • Code of Conduct support and process harmonization • Investigation of compliance misconducts including corrective and disciplinary actions

Supervisor of 16 QM managers worldwide (USA, Europe, China, Japan) • Consultant in quality, regulatory and operational questions ( ISO 9001, ISO 13485, GMP, GDP, FDA, CFR, SFDA, Advamed, Eucomed) • Global QM responsibility of worldwide subsidiaries and a production plant in China • Development and rollout of the worldwide QM strategy, Identification, development and implementation of worldwide policies • Process harmonization (worldwide) of high risk procedures.

• Process improvements, process workflow automation, CRM, supplier assessment • Internal audits and risk management • ISO 9001, ISO 14001 certification • Cross functional responsibility (F&A, HR, Project Controlling interface to QM) • International and external process harmonization with worldwide subsidiaries, employee trainings

• Quality assurance, verification & validation, defect-tracking system • Clinical usability testing of patient monitors and information systems in Europe and the USA • Documentation for medical device registration (510k and CE) of various patient monitors • Product-life-cycle and software engineering, SW analyses, FMEA, fault tree analysis, risk assessment • Cross-functional practice with development, regulatory affairs, technical marketing, procurement, production and clinical affairs

• Plant manager (15 employees) • Personnel planning of technicians, service employees and outsourcing to external service providers • Product development in-house and in cooperation with international partners • National and international customer care

General Management, Strategic Management, Entrepreneurship, Business Law, HR Management etc.

Medizintechnik, Energie-Technik, University Louvain-la-Neuve, Belgium