Regulatory Affairs Manager - IVD Instruments and Software

F. Hoffmann-La Roche AG; Tucson (AZ); Hybrid; USD 106,000 - 197,000; Full time

Benefits offered by this job

Discretionary bonus

Job summary

Roche is seeking a Regulatory Affairs professional to support submission compilation for complex diagnostic products within the Pathology and Digital Pathology portfolio. You will interface with stakeholders across functions and countries to shape regulatory pathways and patient access.

The role emphasizes developing strategies, audits support, and leading parts of global projects while partnering with external customers to navigate evolving regulatory environments. Hybrid, Tucson-area position.

Qualifications

• Bachelor’s or Master in Life Science or related field; advanced degree preferred.
• 3–5 years with PhD, 5–7 with Masters, 6–8 with Bachelor in regulatory affairs or equivalent.

Responsibilities

• Oversee regulatory document and submission compilation for complex products.
• Develop and manage portions of global regulatory submissions and registration plans.
• Apply knowledge of US FDA regulations for IVD instruments, software, accessories and systems.
• Lead audits support and collaborate with external stakeholders to influence strategies.

Skills

Regulatory Affairs

USFDA knowledge

Stakeholder management

Global regulations

Education

Bachelor's/Master Life Science

Advanced degree preferred

Job description

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. Join Roche, where every voice matters. The Position A 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.

Benefits

Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.