Regulatory Affairs Specialist Systems & Software (m/f/d)

Sub Category General Regulatory Affairs

Hiring Type Full time

Job Level Individual Contributor

Posted Date 01-10-2025

Job Type Regular / Permanent

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people-s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

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The Position

A healthier future. It-s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That-s what makes us Roche.

The Opportunity

Roche is seeking a dynamic and highly motivated individual to join our team as an International Regulatory Affairs Professional. We are looking for candidates who bring an innovative and creative mentality to the table, along with a proven track record in the Regulatory Affairs field. If you are passionate about making a positive impact on global healthcare through regulatory perfection, we invite you to be part of our dedicated team.

• Collaborates with other functions to acquire regulatory approvals and maintains product registration throughout its lifecycle. Coordinates timely document compilation for submissions and fosters clear agreements with stakeholders and external partners
• Develops understanding of regulatory frameworks like IVDR and applies it to build and manage regulatory strategies and submissions for simple-to-moderate complexity products
• Builds effective relationships with stakeholders, understands their needs, communicates effectively, and manages stakeholder expectations
• Works independently with minimal direction, presents issues and solutions, and exercises good decision-making principles by gathering vital information and thinking through problems clearly
• Drives innovation, generates new ideas, seeks new opportunities, troubleshoots issues, and implements cost-effective actions to complete daily work without jeopardizing compliance
• Acts with integrity, courage, and passion, embraces diversity, takes initiative, develops an agile mindset, and encourages others to do the same. Identifies and acts on improvement opportunities and embraces new technology
• Establishes strong collaborative relationships, contributes as a team member, shares information and knowledge, resolves conflicts, listens well, expresses ideas clearly, and recognizes the contributions of colleagues

Who you are

• Second-level education, high school diploma (Abitur), and Bachelor's/Master's degrees or equivalent experience (e.g., technician or laboratory technician with extensive experience)
• Training in a scientific field such as biology, biochemistry, or analytical chemistry
• 1-5 years of professional experience in areas like Regulatory, R&D, Quality, Operations, or Clinical Operations, with experience in lab diagnostics and the ability to manage moderately sophisticated projects
• Proficiency in MS Office, databases, and document management; proficient in English (spoken and written). Desirable knowledge: regulatory requirements for IVDs, including laws and standards
• Understanding of healthcare regulatory frameworks, basic regulatory strategy knowledge, and willingness to travel for business purposes

Are you ready to apply? We want someone who thinks beyond the job offered - someone who knows that this position can be an outstanding opportunity to craft the future of Roche.

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 Diagnostics International in Rotkreuz is a leading provider of diagnostic systems solutions, and the largest manufacturer of fully automated in vitro diagnostic systems in Switzerland. We are more than 2-700 passionate colleagues from over 65 nationalities. Find out more about our site in Central Switzerland, here.

Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.

We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.

Roche is an Equal Opportunity Employer.