Quality, Regulatory and Compliance Specialist (Diabetes Care)

Job description

The Position

This role will suit to someone whose passion is managing Quality, Regulatory & Compliance related processes. It is based within the Diabetes Care (DC) division. You will act as a partner to the internal and external stakeholders whilst supporting and contribution to maintain and strengthen our reputation and license to operate local and/or global principles and policies.

This role is project based for 12 months initially with a possibility to prolong.

Challenges and Career Opportunities

• Foster a holistic compliance culture across the organization, identify continuous improvement opportunities, and enable speak up culture
• Set up the local processes and governance for corporate & personal integrity
• Perform risk assessment via CARISMA, identify risks, implement internal controls, and monitor annually
• Train on all relevant Roche Directives, Guidelines, DC Standards, SOP, and industry associations regulation
• Follow up on the completion of corporate e-learning in order to comply with global Directives and report and document non-compliance cases and mitigation measures
• Drive internal compliance campaigns
• Developing local regulatory strategy in cooperation with DC Head to ensure DC products are registered in a timely manner and business objectives are met (this includes submitting technical documentation to Regulatory Authorities and securing registration approval in a timely manner)
• Handling of Safety Board notifications and implementation of Field Safety Corrective Actions, handling of QNs, SNs and Product Information

Who you are

• Law University Degree is preferred, similar qualification from economy, management, business administration is desirable but also other fields of studies apply
• Experience from a similar License to Operate job role is a plus, not a requirement
• Lithuanian language fluent
• English language fluent
• Excellent interpersonal skills, including clear, sufficient and timely communication and proven ability to foster and build important relationships with customers and key stakeholders
• Strong presentation skills and articulating your ideas
• Able to work independently and handle conflicting priorities
• Contribute to a great teamwork
• You like solving problems and challenges
• Open minded with an eagerness to innovate, learn and change
• Enjoys working in a multi-culture network environment

Who we are

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.