Overview As Global Head of Regulatory Affairs at Roche Diagnostics Solutions, you lead a high impact regulatory function that enables global access to our diagnostics portfolio. You will build and coach a multinational RA team, set global submission strategies, and partner with senior leaders to embed agile, innovative ways of working. Your work shapes how we secure timely registrations and drive patient access across regions. This is a mission critical role at a company committed to scientific rigor, ethics, and improving healthcare worldwide.
Compensation / Benefits- relocation benefits
- salary range provided for primary location
- discretionary annual bonus
- opportunity to impact patient access to diagnostics
- integration with a large global employer
- equal opportunity employer
Responsibilities- Provide strategic direction for Global Regulatory Submissions across Europe, the US, and APAC with regional teams
- Serve as the regulatory contact for US FDA, international regulators, and Affiliates
- Collaborate with Roche Diagnostics affiliates to ensure timely submission data for rapid patient access
- Monitor regulatory environments and assess impacts of new regulations for Customer Areas
- Drive best in class regulatory processes, submission strategies, and lifecycle registrations
- Operate in a matrixed organization with strong stakeholder management and resource alignment
- Standardize processes and reuse assets and technical standards while balancing creativity
- Foster an agile mindset to deliver high quality submissions
- Provide leadership aligned with Roche values and Diagnostics culture
- Own product registration strategy, RA resource allocation, QMS modules, and on time delivery to lifecycle teams
- Grow RA team technical capabilities and manage knowledge within the function
- Inspire the team to develop ground breaking solutions that maintain Roche Diagnostics' leadership
Key requirements- 15+ years of progressively responsible regulatory management experience (international and US)
- Experience in Diagnostic Imaging (Dia) or Medical Technology (MedTech) or both
- Proven track record in regulatory filings (510(k)s, PMAs, IDEs, global dossiers) and negotiations with US FDA
- 5-7 years leading and managing teams and budgeting
- Relevant university degree (post graduate qualifications preferred)
- Strong leadership in global, matrixed environments and cross functional collaboration
- Experience with regulatory communities and external negotiations (CDRH, RAPs, MDIC, AdvaMed)
- Ability to lead with strategic thinking, analytics, and innovation
- Willingness to travel internationally for business needs
- visionary leadership
- collaboration
- excellent communication
- Regulatory submissions strategy (global)
- FDA regulatory processes (510(k), PMA, IDE)
- QMS modules and IT systems related to registrations
