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.

The Position

This role is for a temporary one-year contract with the possibility of extension.

The successful candidate will be employed by a third-party agency on behalf of Roche.

You will be part of the Roche DIA Adriatic Integrity & Impact Department, based in Bosnia & Herzegovina, collaborating with colleagues on implementing the overall Regulatory and Vigilance strategy and activities for Roche Diagnostics.

Key Areas of Responsibilities

• Lead the registration and renewal of IVD medical devices in the RA Register, ensuring all technical documentation is accurate and compliant.

• Prepare and manage notifications of change in strict accordance with the EU IVDR Directive (2017/746) and monitor ongoing implementation requirements.

• Maintain meticulous physical and electronic records of all registration requests and expert opinion submissions for non-IVD products.

• Act as the local lead for the RIMS MedTech platform, ensuring global regulatory data is updated and accurate.

• Serve as the primary backup for Safety Board notifications, implementing immediate communication strategies and decisions in the absence of the responsible person.

• Liaise with local distributors and regulatory authorities to collect and submit critical safety documentation and customer notifications.

• Partner with local distributors to prepare comprehensive documentation for competitive tender processes.

• Provide oversight and coordination for clinical trials as required by the business area.

• Engage in local and global meetings and training to align local regulatory activities with international standards.

Who You Are

• University Degree in Life Sciences: Pharmacy, medical or dental degree

• Demonstrated work experience in the pharmaceutical industry, preferred the medical devices field

• Fluency in the local and English languages (written and spoken)

• Ability to handle conflicting priorities 

• Proven organizational and planning skills 

• Demonstrated knowledge about the medical devices regulatory processes and overall healthcare knowledge

• Ability to create and maintain efficient working relationships within matrix driven organization

• Proven communication skills to lead data and arguments driven discussions with different cross-functional teams

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.