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Head of Legal & Safety, Regulatory and Quality / Compliance Officer oversees and is responsible for all legal, compliance and regulatory matters of the company. You will collaborate with other company departments and external advisors in areas that overlap with law and regulation as well as identify risks to the company and help relevant colleagues design and implement corrective actions.

You will lead a department of six people, be member of the Diagnostics Leadership Team in the Czech Republic with the reporting line to Country Manager.

Career Opportunities and Challenges

Provide legal advice on a wide range of commercial arrangements, challenges, and opportunities on matters including but not limited to antitrust, data privacy, distribution arrangements, public procurement, anti-bribery regulation, regulatory, employment, digitalization and product liability 

Risk management and supervision of legal actions in line with the Czech Republic legislation and standards

Monitor and keep up to date with the development of legislation and its upcoming changes, especially in the areas of public procurement and legal regulation of medical devices followed by communicating and providing training about legal topics to other employees

Partner with the business in tender processes by identifying and analyzing opportunities and mitigating legal risks; leading contract negotiation with key customers and/or stakeholders such as administrative authorities, SÚKL, ÚOHS, Ministry of Health

Manage corporate law matters (e.g. board of directors meetings, appointment of directors, granting of powers of attorney, corporate law operations, commercial leases, delegations of authorities, inter-company agreements)

Coordinate and align with the Diagnostics Regional Lawyers and connecting with the Roche Legal and Compliance network to source and share best practices 

Provide guidelines and advice on issues related to behavior in business (cooperation with line managers)

Ensure synergy and cooperation between local divisions and regional and global compliance experts

Oversee local compliance activities that reflect the \"value of integrity in business\", ensuring familiarity with all rules, SOPs, guidelines 

Manage compliance monitoring and audit activities

Compliance Risk Management and Compliance Assurance

Business Ethics Incident Resolution and Reporting (BEIR)

Monitor and evaluate key performance indicators (KPIs) defined by the Global Quality and Regulatory department

Lead the implementation of modules within mQMS, including the creation of local Standard Operating Principles (SOPs) and relevant training in close cooperation with the LSO

Manage and monitor training progress in accordance with DS/GSOPs, or mQMS

Supervision of the creation, implementation and updating of the quality management system process according to ISO 9001:2008

Act as an intermediary between external parties and company departments for issues related to the quality management system

Act as a local contact for GQC and as a link for sharing quality management information

Who You Are

Law degree from a reputable University

Lawyer qualified in the Czech Republic

Proven 8+ years’ work experience, obtained via a combination of private practice and in-house, preferably in the medical device, biotech, or pharmaceutical industries

Fluent English language and Czech language on native level

Knowledge of the healthcare environment (legislation awareness in this area)

Presentation and public speaking skills to be able to convey a message to the target audience

Ability to explain complex topics in a comprehensive manner to colleagues from different functional areas

Able to handle conflicting priorities and thrive in a fast-paced environment

Proven decision-making skill 

Act as an advisor and thought partner that enables informed strategic choices within and acceptable legal risk profile

Problem-solver with systematic approach focusing on solutions rather than barriers

Business acumen 

Proven people management and coaching skills

Internal and external stakeholder-management skills to bring and maintain efficient collaboration

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.