Regulatory Affairs Specialist

RocheSant Cugat del VallèsonsiteSalary not postedView the original posting at Roche ↗

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 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. As a Regulatory Affairs Specialist , you will partner closely with cross-functional internal teams and external stakeholders to bring life-changing diagnostic solutions to market. In this role, you will prepare high-impact submission dossiers for Health Authority approvals and champion agile principles to drive regulatory milestones within our Oncology In-vitro Diagnostics (IVD) team. What You Will Do Regulatory Submissions & Strategy: Lead and coordinate the preparation of registration dossiers for products and programs of moderate complexity. Formulate sound regulatory submission plans to secure market access globally. Health Authority & Compliance Frameworks: Apply knowledge of global regulations (e.g., IVDR, FDA, ISO 13485) to establish robust regulatory pathways that keep Roche products legally and ethically compliant. Stakeholder Partnership & Audits: Cultivate enduring, collaborative relationships with internal partners and external regulatory bodies. Actively contribute to inspection and audit readiness, execution, and corrective actions. Problem-Solving & Innovation: Work with autonomy to identify operational bottlenecks and propose practical, forward-looking solutions. Champion continuous improvement and explore new digital tools or automated workflows to drive efficiency. VACC Leadership & Agile Mindset: Embody the spirit of “We all lead” through the VACC model (Visionary, Architect, Catalyst, Coach). Act with integrity, courage, and passion while fostering an inclusive, high-trust team environment. Who You Are You are someone who wants to influence your own development. You are looking for a company where you have the opportunity to pursue your interests across functions and geographies, and where a job title is not considered the final definition of who you are, but the starting point. Required Qualifications & Experience: Education: University degree (Bachelor’s or Master’s) in Life Sciences, Biotechnology, Biomedical Engineering, Data Science, or a related field (or equivalent practical experience). Professional Experience: 1+ years of relevant experience within Regulatory Affairs, Quality Assurance, R&D, or Clinical Operations in healthcare or life sciences. Digital & IT Fluency: Proficiency in MS Office and Electronic Document Management Systems (EDMS/RIMS). Communication: Fluency in English (both written and spoken), with the ability to communicate regulatory concepts clearly across diverse teams. Preferred / Nice-to-Have: Hands-on experience with IVD (In-vitro Diagnostics) or Medical Device regulations (EU IVDR 2017/746, US FDA 510(k)/PMA, etc.). Exposure to process automation, robotic workflows (RPA), or AI-enabled regulatory tools. Familiarity with international quality standards (e.g., ISO 13485). 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 deliv

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