Regulatory Affairs Manager – Cardiac & Neurology

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.

At Global Regulatory Affairs our aspiration is to be the world's best Regulatory organization, championing patient access to the world's best diagnostics. Focus of our work is the global approval of in-vitro-diagnostics of the Elecsys immunoassay product portfolio. Our dynamic team manages regulatory projects as well as overarching regulatory topics.

Join an open-minded work environment where close collaboration with colleagues across various departments and countries is not just encouraged, but essential.

In this high-impact strategic role, you will champion patient access to cutting-edge diagnostic solutions by leading global regulatory strategies for our Elecsys immunoassay portfolio, specifically focusing on complex cardiometabolic and neurology product lines.

Provide global strategic regulatory direction and represent Regulatory Affairs within international, cross-functional project teams to build a highly collaborative and fruitful work environment.

Drive and manage end-to-end product registrations for high-burden cardiology and neurology reagents in the United States, Europe, and China, while steering supporting registration frameworks worldwide.

Act as the primary interface and lead communication with global health authorities, including the FDA and European Notified Bodies, to expedite premarket submissions, clearances, and responses.

Deliver clear, proactive regulatory guidance on strategic and tactical objectives to cross-functional stakeholders and key business customer areas.

Hold accountability for lifelong product care activities, ensuring technical documentation and dossiers remain compliant with evolving global medical device and IVD regulations.

Foster deep collaboration across global chapters and cross-regional teams—spanning Germany, Switzerland, the US, China, and Japan—to optimize time-to-market and ensure international compliance alignment.

You bring a sophisticated blend of scientific insights and regulatory acumen, coupled with a passion for collaborating across borders to overcome complex healthcare challenges.

Education & Background:
University degree (Bachelor’s, Master’s, or PhD) in Life Sciences, Data Science, or a related field, combined with substantial professional experience in Regulatory Affairs, R&D, or Clinical Development within the IVD, medical device, or biopharmaceutical industries (typically 5–8 years depending on degree level).

Regulatory Expertise:
In-depth knowledge of international laws and regulatory frameworks governing the development, manufacturing, and registration of in-vitro diagnostics (IVDs) or medical devices, with specific emphasis on EU (IVDR), US (FDA), and China (NMPA) frameworks.

Domain Knowledge:
Deep technical understanding of IVDs; experience with immunoassay technologies (Elecsys portfolio or similar) and managing complex indications (such as cardiac or neurology markers) is highly desirable.

Strategic Agency Interaction:
Proven track record of direct collaboration and successful communication with major regulatory bodies and health authorities to achieve product approvals.

Agility &

Collaboration:

Excellent self-organization skills with a demonstrated ability to operate independently, adapt seamlessly to shifting priorities, and manage overlapping global projects.

You value diverse perspectives and leverage strong relationships to achieve meaningful results together.

Locations:
Penzberg (Germany), Mannheim (Germany), Indianapolis (USA), or Sant Cugat (Spain) - At the Company's discretion, an exception to the location requirement could be made.

Standorte:
Penzberg (Deutschland), Mannheim (Deutschland), Indianapolis (USA) oder Sant Cugat (Spanien)…