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 Who We Are A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche. The Regulatory Affairs Systems and Software organization is responsible for requirements related to platform developed with internal and external partners. In this role, you will manage Regulatory activities and support the product care activities of the assigned product portfolio. You will assess and communicate regulatory risks and challenges to project and lifecycle teams. In this particular role, you will plan deliverables with other Regulatory Affairs professionals (USA, Canada, China etc.) for product registrations, including compilation of corresponding Software and Hardware-Reports. You can expect an open-minded work environment, where you will be working closely with colleagues in other departments and other counties. 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 to adapt to the 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 worldwide 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. Who You Are * You have a Bachelor's / Master degree in Life Science, Data Science or related subject or equivalent experience. An advanced degree is considered an advantage. * You have 5+ years experience with PhD degree, 7-10 with Masters degree and 8-10 years with Bachelor degree in the field of IVDs/Medical devices/Pharma/Biopharmaceutical with significant experiences in Regulatory Affairs or equivalent. * You have knowledge of the European, US, China and International regulations and demonstrated ability to adequately interpret and implement quality standards considered an advantage * You have demonstrated the ability to manage even the highest complexity of work and/or global projects. * Submission expertise and demonstrated experience successfully partnering with the FDA is highly preferred. * Regulatory affairs experience in the systems and software space is highly preferred. * Experience with systems including IVD/MD/RUO instruments/analyzers and corresponding software is highly preferred. Locations You are preferably based out of Indianapolis, Branchburg or Washington DC. We will consider remote work arrangements under exceptional circumstances. Relocation Assistance is not available. The expected salary range for this position based on the primary location of Indianapolis is $121,000 and $226,000. 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.