Regulatory Affairs Project Manager (m​/f​/d

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.

Penzberg, Indianapolis and Mannheim. At the Company's discretion, an exception to the location requirement could be made.

At Roche, we are passionate about transforming patients’ lives and we are fearless in both decision and action – 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.

At Global Regulatory Affairs, we strive to be the world's best Regulatory organization, championing patient access to the world's best diagnostics. The focus of our work in the Subchapter Cardiology, Endocrinology and Fertility is the global approval of in-vitro-diagnostics of the Elecsys and Point of Care solutions product portfolio. Our team is tasked with regulatory projects as well as overarching regulatory topics.

You can expect an open-minded work environment, where you will be working closely with colleagues in other departments and other counties.

In this role, your main purpose and tasks will be the following:

• Provide strategic direction and representation of Regulatory Affairs in international and interdisciplinary teams in order to create an impactful and fruitful work environment.
• Manage cardiology, endocrinology, women’s health or critical care product registrations in Europe, United States and China and support worldwide registrations.
• Prepare and submit premarket submissions to FDA or Notified body serving as the primary interface to Health authorities.
• Interact with regulatory agency personnel in order to expedite approval or clearance of pending registration and answers any questions.
• Be accountable for supporting product care activities and updating the technical documentations of the product portfolio.

In order to achieve efficient approvals worldwide, you work in close collaboration with colleagues in Germany, Switzerland and the US within and across chapters as well as with global Regulatory Affairs teams, especially in China and Japan.

High degree of subject matter expertise:
Bachelor’s / Master degree in Life Science, Data Science or related subject minimum 5 years of experience in Regulatory, R&D, Quality, Operations or Clinical Technical understanding of medical devices or IVDs Knowledge in international laws and regulations for development, manufacturing and registration of IVDs especially in EU, US and China Experience in working on overlapping projects - i.e. good at juggling multiple projects, multitasking and organizing yourself Project management expertise in an agile environment Excellent knowledge of English.

Additional knowledge of another language is an advantage.

Further competencies and the mindset that you bring to the role:
Courage, vision and drive to be at the forefront of innovative change Strong track record of building and nurturing capabilities such as quality and compliance knowledge, regulatory expertise, communication and stakeholder management. You enjoy working in an international setting in matrix structures in a global environment. You are flexible and thus able to shift priorities while balancing commitments and daily work requirements, independently You are able to make decisions to complete daily scheduled and unscheduled activities and initiate interactions across departments as applicable.

You have courage to make decisions even outside of scope/comfort zone. You see seek candid feedback and act on it You recognize the contributions of teammates and peers and establish strong collaborative relationships inter-departmentally and across the sites. You…