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The Position
About the Role
Are you a detail-oriented professional with a strong background in quality management, medical device regulation, and cross-functional communication? ROCHE s.r.o. is seeking a Local Safety Officer to oversee compliance, documentation, and safety reporting while supporting customer-facing and internal operations in the Czech Republic.
In this multifaceted role, you will act as a pivotal bridge between global divisional standards, local authorities (such as SÚKL), and internal teams to ensure operational excellence and product compliance across the market.
Key Responsibilities
1. Quality & Process Documentation Management- ISO 9001 Compliance: Maintain and update ISO 9001 documentation (SOPs, Internal Directives, Organizational Context) in close collaboration with the management team, ensuring readiness for internal and external QM audits.
- Global Standard Integration: Implement Roche GmbH divisional standards within ROCHE s.r.o. Czech Republic or transfer implementation to designated functional owners.
- Platform Administration: Manage the eLabDoc module on the DiaLog platform (uploading local product documentation) and coordinate employee training uploads in Cornerstone alongside HR.
- HR Support: Support the creation and timely updating of Job Profiles for new hires.
2. Safety Board, Regulatory & Authority Liaison (Local Safety Officer)- Primary Contact: Act as the local primary point of contact for Safety Board matters, local regulatory bodies (e.g., SÚKL), and Field Safety Corrective Actions (FSCA) / adverse incident reporting.
- Safety Board Execution: Promptly execute Safety Board decisions, communicate instructions, and escalate local regulatory queries or product quality/safety information.
- Customer Safety Notifications: Partner with Product Managers, Application Specialists, and Logistics/Finance to distribute Important Notes and Field Safety Notices to prevent adverse events.
- Customer Directory: Maintain and update the customer contact database for electronic product safety alerts.
- Medical Device Registration: Manage the Medical Device Register (under SÚKL authority) to ensure timely registration of Roche IVD (In-Vitro Diagnostic) products distributed in the Czech market.
3. Operational & Customer Support- Document Localizations: Coordinate translation processes for essential product documentation (operator manuals, package inserts, SDS, CE certificates) in line with IVDD guidelines.
- Digital & Physical Distribution: Maintain localized product information on web platforms (ROCHE s.r.o. website, DiaDoc) and manage physical distribution (e.g., package insert updates on CD) as required.
- Specialized Support: Provide CE translations for Tender Specialists and furnish non-public certificates upon customer request.
- Self-Testing Product Labelling: Collaborate with the Head of Sales NPT to design, approve, print, and inspect Czech language packaging labels for patient-directed self-testing products.
What We Are Looking For
- Regulatory & Quality Expertise: Proven understanding of ISO 9001 quality management systems and medical device/IVD regulatory frameworks in the Czech Republic (SÚKL).
- Cross-Functional Collaboration: Strong ability to work effectively across departments (HR, Sales, Logistics, Finance) and build trust-based working relationships.
- Analytical & Decisive Mindset: Ability to gather relevant data, approach problems logically, and make timely, informed decisions.
- Effective Communication: Clear oral and written communication skills in Czech and English, with an emphasis on active listening and transparency.
- Adaptability & Innovation: Comfort with changing priorities, openness to new tools and methodologies, and a drive to improve existing processes.
- Customer Focus: Strong commitment to meeting customer needs and ensuring product compliance and patient safety.
Key Competencies for Success at Roche
- Strategic Alignment: Aligning daily responsibilities with organizational mission and adapting plans to dynamic conditions.
- Inspiring & Influencing: Persuasively advocating ideas and collaborating across functional lines without direct authority.
- Results Orientation: High accountability, persistence, and focus on delivering high-value outcomes.
- Feedback & Development: Proactively seeking feedback, continuous learning, and fostering a supportive team environment.
Who we are
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.