Senior Manager Regulatory Affairs - Systems & Software

Roche; United States; On-site; USD 130,000 - 190,000; Full time

Job summary

Roche in the United States seeks a Senior Regulatory Affairs Manager to shape regulatory strategies for complex instruments, software, cybersecurity, and digital technologies, guiding submissions and market access across regions.

You will partner with cross-functional teams, mentor junior staff, manage health authority interfaces, and drive lifecycle management while balancing risk, timelines, and patient safety in a rapidly evolving global landscape.

Qualifications

• Extensive experience guiding global regulatory submissions for complex products.
• Proven ability to influence strategies and decisions across functions.
• Experience managing authorities and audits.
• Strong knowledge of regulatory requirements for medical devices and digital health.
• Excellent stakeholder management and negotiation skills.

Responsibilities

• Oversees the development of submission/product registration dossiers of the most complex products/programs.
• Leads external complex initiatives with key stakeholders and authorities.
• Drives regulatory knowledge and strategy to adapt to evolving environments.
• Leads complex initiatives with stakeholders to align Roche's regulatory direction.
• Makes timely decisions and supports compliant product development.
• Fosters innovation, problem solving, and continuous improvement in regulatory processes.
• Role model for leadership and inclusive collaboration.

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

This is an exciting opportunity to help shape the future of pathology within a market-leading organization with a strong pipeline of innovative instruments, software, and digital solutions. As a Senior Regulatory Affairs Manager, you will be a strategic regulatory partner to cross-functional teams, influencing key decisions from early development through global market access and lifecycle management. You will have the opportunity to navigate complex and evolving regulatory areas-including integrated instrument systems, software, cybersecurity, automation, connectivity, and digital technologies-while helping translate innovation into regulatory strategies that enable successful product development and commercialization. This role offers significant visibility, autonomy, and opportunity to influence, making it ideal for an experienced regulatory professional who enjoys solving complex problems, shaping strategy, and seeing their work directly contribute to the future of pathology and patient care.

The Opportunity

Regulatory document and submission compilation:

Oversees the development of submission/product registration dossiers of the most complex products/programs. Develops and manages comprehensive global regulatory submissions and registration plans. Mentors more junior team members in this area.

External interface management:

Leads external complex initiatives including the collaboration with key stakeholders. Cultivates and utilizes external relationships that significantly influence the current and future direction for Roche and our products. Challenges and resolves complex issues and overcomes organizational barriers. Develops/maintains health authority relationships and actively shapes the regulatory environment. Has the ability to represent Roche in audits and other complex stakeholder negotiations.

Regulatory knowledge and strategy :

Lead the organization adapt to evolving regulatory environment and requirements. Experience in solving complex, critical health authority issues or equivalent understanding of external environmental changes, precedents, to navigate complex situations and influence strategies and decision making. 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. Proactively creates unique/innovative regulatory strategies and influencing approaches to avoid regulatory obstacles and accelerate world wide approvals.

Stakeholder management and influencing :

Leads complex initiatives including collaboration with key stakeholders. Cultivates and utilizes relationships that significantly influence the current and future direction for Roche and our products. Challenges and resolves complex issues and overcomes organizational barriers. Ability to shift the perspectives of key stakeholders to achieve a specified goal. Builds common ground and alignment even if initial positions were far apart. Negotiates to maximize value for Roche and stakeholders so we have biggest impact for customers and patients.

Decision making:

Has courage to make decisions even outside of scope/comfort zone. Proactively initiates activities independently and initiates interactions across departments as applicable. Embrace the good decision making principles. Pushes decision making to the lowest appropriate level. Commits to decisions that have been made. Shows good judgment in decision making. Makes good decisions without necessarily having all the information in a timely manner.

Innovation and problem solving:

A mindset of creativity and experimentation - a true trailblazer and support radical simplification as well as continuous innovation. Challenges the organization to be curious, question the status quo and adopt new approaches. Fosters a culture that leverages unique perspectives. Has vision; often brings up ideas about potentials and possibilities for the future. Actively drives new ideas/ approaches into the business. Able to troubleshoot issues as they arise, independently develop and implement cost effective and non-complex actions solutions to ensure that daily work is completed without jeopardizing compliance. Identifies problems before they occur and actively drives mitigation strategies to avoid them. Leads others in problem-solving activities.

VAAC Leadership and agility:

Role model for we all lead . Actively develops VACC competencies and deploys them in our daily work. Fosters an inclusive environment. Sho