Regulatory Affairs Specialist

1624 Roche Diagnostics S.L.; Sant Cugat del Vallès; On-site; EUR 45,000 - 65,000; Full time

Job summary

Roche is seeking a Regulatory Submissions professional to lead dossier preparation for moderate‑complexity products and to craft global submission plans for market access. You will apply knowledge of IVDR, FDA, and ISO 13485 frameworks to ensure compliant pathways and collaborate with internal teams and external regulators.

With 1+ years in Regulatory Affairs, QA, R&D, or Clinical Operations, you will use MS Office and EDMS/RIMS to manage documents, drive improvements, and support audits.

Qualifications

• University degree in Life Sciences, Biotechnology, Biomedical Engineering, Data Science, or related field (or equivalent practical experience).
• 1+ years of relevant experience within Regulatory Affairs, Quality Assurance, R&D, or Clinical Operations in healthcare or life sciences.
• Fluency in English (written and spoken) and proficiency with MS Office and EDMS/RIMS.

Responsibilities

• 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.
• Apply knowledge of global regulations to establish robust regulatory pathways for compliance.
• Cultivate enduring relationships with internal partners and external regulatory bodies.
• Champion continuous improvement and explore digital tools or automated workflows to drive efficiency.

Skills

Regulatory knowledge

Documentation

Communication

MS Office

EDMS/RIMS

Education

Bachelor's or Master’s in Life Sciences or related

Tools

EDMS/RIMS

Job description

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.

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:

Embed 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 deliver life‑changing healthcare solutions that make a global impact. Let's build a healthier future, together.

Roche is an Equal Opportunity Employer. We believe it's urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients' lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.