At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

We are looking for a Regulatory and Quality Manager at Roche Diagnostics.

     What will you do?

You ensure all product related local and global requirements for registration.

You supervise all kinds of registration procedures of the products, to obtain documentation related there of from company’s relevant global functions. Mastery of all IVD product local registration processes and coordination with functions such as product management, sales and tenders.

You coordinate regulatory documentation activities, obtain overseas documents required for tenders and other legal procedures and participate meetings with regulatory body when necessary.

You update and maintain the quality assurance system aligned with global standards and local requirements in Management Center Turkey and CENACA 

You contribute to the setup of  your country chapter as a business enabling function supporting the business in all Q&R-related matters, in particular in regards to local Q&R compliance status, timely product registration according to approved launch plans, business challenges that need support from Q&R

You are responsible for local product registration activities, including creation of required documentation and interface to local authorities in close collaboration with our global DC Registration area

You serve as a point of contact and escalation body for all Q&R-related activities in assigned countries and beyond

You participate in network activities and proactively share best practices and learnings with the goal to further improve the Q&R landscape in and across country chapters

You prepare the organization for internal and external audits in collaboration with internal & external stakeholders and perform the action plans.

You manage and execute the ISO 27001 Information Security Management System, ensuring it is effectively integrated with other existing quality systems, and work in collaboration with the Information Security Management System Team, IT Team, Security Officer, DPO and relevant departments. 

You ensure compliance with ISO 9001 standards and coordinate quality management activities.

You monitor and evaluate supplier relations in terms of information security and quality

You manage Learning Management System and learning related activities 

Qualifications:

University Degree in related fields, min 7 years of experience

Information Security and Quality experience 

Strong knowledge and experience in  ISO 9001 standards

Basic knowledge of ISO13485, ISO 27001 and software quality requirement

Internal auditor certificate and audit experience

Experience in warehouse quality standardization

Proactive and a team worker with growth mindset

Fluency in English and Turkish

Able to quickly and consistently establish rapport and collaborate effectively with all the relevant stakeholders (clients, team members, partners, public bodies etc.)

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.