Regulatory Affairs Manager – Cardiac & Neurology — Roche
- Location
- Basel
- Contract
- full-time
- Posted
- 2 days ago
Role overview
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.
- 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.
Company and context
- 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. The Opportunity
- 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.
Additional details
- Join Roche, where every voice matters. for German version please see below
- Join an open-minded work environment where close collaboration with colleagues across various departments and countries is not just encouraged, but essential.
- 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 value diverse perspectives and leverage strong relationships to achieve meaningful results together. Locations: Penzberg (Germa
Notes and original content
- Join Roche, where every voice matters.
- The Position
- for German version please see below
- The Opportunity
- Who You Are
- You value diverse perspectives and leverage strong relationships to achieve meaningful results together.
- Locations: Penzberg (Germa
Questions about this listing
What salary does Roche offer for this role?
Roche lists CHF 85'500 - 129'500 gross per year for this position in Basel. This is the salary published in the original listing (or, when the employer omits a figure, a realistic estimate for the role and sector) — the calculator on this site converts it to your actual net take-home once cross-border tax and social contributions are applied.
Is this a full-time role, and what type of contract does Roche offer?
This listing is a full-time position. The contract type shown here comes directly from the employer's original posting; always confirm exact hours, notice period and probation length with Roche during the application process, since these details can vary by role even within the same contract category.
Do I need a cross-border work permit for a role in Basel?
EU/EFTA residents living in the border zone of the country adjoining Canton Basel can apply for a G permit; the Swiss employer files it with that canton's migration office after the contract is signed. Border-zone rules and processing times vary by neighbouring country and canton, so confirm the specifics with Basel's cantonal migration office or with HR during the application.
How do I apply for this position at Roche?
Use the "Apply now" button on this page — it links directly to Roche's original listing at roche.wd3.myworkdayjobs.com, so your application goes straight to the employer's own applicant-tracking system. Frontaliere Ticino does not collect or forward applications itself.
