Regulatory Affairs Manager - IVD Instruments and Software

The Position

At Roche Global Regulatory Affairs, we help bring the world's leading diagnostics to the people who need them. In this role, you'll support regulatory projects and strategic topics across Laboratory Instruments, consumables and Software, including integrated hardware and software instrument systems. Your focus will be our Pathology and Digital Pathology portfolio within the Pathology Customer Area.

The Opportunity

• Oversee regulatory document and submission compilation, including development of submission/product registration dossiers of more complex products/programs; develop and manage parts of comprehensive global regulatory submissions and registration plans; bring knowledge of USFDA regulations including IVD Instrument and Software, Accessories and System Reagents
• Interface with external management; understand structure, key roles and responsibilities of external customers/stakeholders and communicate timely and effectively; build effective and enduring external relationships; contribute to audits by supporting preparation, execution and follow up
• Lead the organization to adapt to the evolving regulatory environment and requirements; interpret and apply understanding of regulators' thinking to projects and apply strategies to different regional needs without significant guidance; proactively create unique/innovative regulatory strategies and influencing approaches to avoid regulatory obstacles and accelerate worldwide approvals
• Effectively partner with and influence stakeholders to understand and provide best solutions; take initiative to address problems or opportunities and involve collaborators for best solutions; develop relationships that significantly influence the current and future direction for Roche and our products
• Have courage to make decisions even outside of scope/comfort zone and proactively initiate activities independently; embrace good decision making principles
• Model VACC Leadership and agility; identify opportunities to develop VACC competency; act with integrity, courage, passion and honor commitments and contribute to an inclusive environment
• Pull people together around a common goal and seek to understand and build on different perspectives to enhance outcomes; address and resolve conflict by creating an atmosphere of openness and trust; bring out the best in people and teams

Who you are

• Bachelor's / Master degree in Life Science, Data Science or related subject or equivalent experience. Advanced degree preferred.
• 3-5 years experience with PhD degree, 5-7 with Masters degree and 6-8 years with Bachelor degree in the field of IVDs/Medical devices/Pharma/Biopharmaceutical with significant experiences in Regulatory Affairs or equivalent
• Demonstrated experience and knowledge of Daily Management and Continuous Improvement best practices
• Knowledge of the European, US, China and other international regulations and demonstrated ability to adequately interpret and implement quality standards considered an advantage
• Demonstrated ability to manage more complex work and/or at parts of global projects

Preferred

• Experience with medical laboratory instruments, accessories, consumables and software product launch strategies for USFDA, EU and other global geographies