Regulatory Affairs Specialist
Company: Roche
- Location: Sant Cugat del Vallès, Spain
- Employment type: Full-time
- Posted: Today
- Offer language: German
Job description
Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zählt.
Die 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 aRegulatory 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, 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).
Wer wir sind
Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.
Gemeinsam können wir eine gesündere Zukunft gestalten.
Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.
