Regulatory Affairs Manager

Position:
Regulatory Affairs Manager – Cardiac & Neurology

Company:
Roche

Location:
Germany (Penzberg, Mannheim), USA (Indianapolis), Spain (Sant Cugat del Vallès)

Employment type:
Full-Time; Permanent

Short Summary:
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, focusing on complex cardiometabolic and neurology product lines.

Responsibilities:
- Provide global strategic regulatory direction and represent Regulatory Affairs within international, cross-functional project teams.
- Drive and manage end-to-end product registrations for high-burden cardiology and neurology reagents in the US, Europe, and China.
- Act as the primary interface with global health authorities, including the FDA and European Notified Bodies.
- Deliver clear, proactive regulatory guidance on strategic and tactical objectives to stakeholders.
- Ensure compliance of technical documentation and dossiers with evolving global regulations.
- Foster collaboration across global teams to optimize time-to-market and ensure compliance alignment.

Requirement:
- University degree (Bachelor’s, Master’s, or PhD) in Life Sciences, Data Science, or a related field.
- 5–8 years of professional experience in Regulatory Affairs, R&D, or Clinical Development within the IVD, medical device, or biopharmaceutical industries.
- In-depth knowledge of international laws and regulatory frameworks for IVDs or medical devices, particularly EU (IVDR), US (FDA), and China (NMPA).
- Experience with immunoassay technologies and managing complex indications (cardiac or neurology markers) is highly desirable.
- Proven track record of collaboration with major regulatory bodies.
- Excellent self-organization skills and ability to manage overlapping global projects.

Benefits:
- Open-minded work environment with close collaboration across various departments and countries.
- Opportunity to work on high-impact projects that contribute to patient access to healthcare.