Regulatory Affairs Manager - IVD Instruments and Software

F. Hoffmann-La Roche AG; Northern (KY); Hybrid; USD 106.000 - 197.000; Vollzeit

Zusammenfassung

Roche’s Global Regulatory Affairs team seeks a regulatory professional to support submissions across Laboratory Instruments, consumables and software, with a focus on Pathology and Digital Pathology. You will build dossiers, manage registration plans, and interact with external stakeholders to secure timely approvals.

Ideal candidates have 3–8 years in regulatory affairs in IVDs/medical devices, broad regulatory knowledge, and the ability to influence strategies across regions.

Qualifikationen

• 3–5 years experience in regulatory affairs (PhD: 3–5; Masters: 5–7; Bachelors: 6–8)
• Knowledge of USFDA, EU and international regulations is highly valued.
• Experience with Daily Management and Continuous Improvement practices.

Aufgaben

• Oversee regulatory document and submission compilation for complex products.
• Develop and manage parts of global regulatory submissions and registration plans.
• Interpret regulators' thinking to adapt strategies for different regions.
• Collaborate with cross-functional teams and external stakeholders to drive timely approvals.

Kenntnisse

Regulatory affairs knowledge

Stakeholder management

Project management

Cross-functional collaboration

Quality standards

Ausbildung

Bachelor’s degree in Life Science

Master’s degree in Life Science

Jobbeschreibung

### The PositionA healthier future. That’s what drives us at Roche. We advance science so more people can access the healthcare they need—today and for generations to come. We work toward a world where everyone has more time with the people they love. That purpose is what makes us Roche. At Roche Global Regulatory Affairs, we help bring the world’s leading diagnostics to the people who need them. We’re looking for a colleague who wants to make a meaningful contribution to that mission. 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. You’ll work in an open, collaborative environment, partnering with colleagues across functions and countries to help shape regulatory pathways and support patient access to innovative diagnostics.**The Opportunity*** You oversee regulatory document and submission compilation, which includes the development of submission/product registration dossiers of more complex products/programs. You develop and manage parts of comprehensive global regulatory submissions and registration plans. Specifically, you bring knowledge of USFDA regulations including IVD Instrument and Software, Accessories and System Reagents* You interface with external management. You understand the structure, key roles and responsibilities of external customers/stakeholders and communicate timely and effectively the needs of external customers/stakeholders. You build effective and enduring external relationships and apply effective stakeholder management practices. You contribute to audits by supporting preparation, execution and follow up.* You lead the organization to adapt to the evolving regulatory environment and requirements. You have an understanding of external environmental changes, precedents, to navigate complex situations and influence strategies and decision making. You have the ability to interpret and apply understanding of the regulators' thinking to projects and apply strategies to the different needs of different regions without significant guidance. You proactively create unique/innovative regulatory strategies and influencing approaches to avoid regulatory obstacles and accelerate world wide approvals.* You effectively partner with end influence stakeholders to understand and provide best solutions. You take initiative to address problems or opportunities and involve collaborators for best solutions. You develop relationships that significantly influence the current and future direction for Roche and our products.* You have courage to make decisions even outside of scope/comfort zone and proactively initiate activities independently. You embrace good decision making principles.* You model VAAC Leadership and agility. You identify opportunities to develop VACC competency. You act with integrity, courage, passion and honor commitments and contribute to an inclusive environment which supports all dimensions of diversity.* You are able to pull people together around a common goal and seek to understand and build on different perspectives to enhance outcomes. You address and resolve conflict by creating an atmosphere of openness and trust. You bring out the best in people and teams. **Who you are*** You have a Bachelor’s / Master degree in Life Science, Data Science or related subject or equivalent experience. Advanced degree preferred.* You have 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.* You have demonstrated experience and knowledge of Daily Management and Continuous Improvement best practices.* You have knowledge of the European, US, China and other international regulations and demonstrated ability to adequately interpret and implement quality standards considered an advantage.* You have demonstrated the ability to manage more complex work and/or at parts of global projects.*Preferred** You have experience with medical laboratory instruments, accessories, consumables and software product launch strategies for USFDA, EU and other global geographies **Locations** You are local to Tucson, Indianapolis, Branchburg, or Carlsbad. This is an hybrid position. Relocation assistance is not available for this position. The expected salary range for this position based on the primary location of Arizona is $106,100 to $197,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.