Regulatory Affairs Manager for Systems & Software (m/f/d)

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position

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 Opportunity

Roche is seeking a dynamic and highly motivated individual to join our team as an International Regulatory Affairs Professional. We are looking for candidates who bring an innovative and creative mentality to the table, along with a proven track record in the Regulatory Affairs field. If you are passionate about making a positive impact on global healthcare through regulatory perfection, we invite you to be part of our dedicated team.

1. Obtain regulatory approvals for products in defined markets through collaboration with other functions; compile and coordinate submission documents to support product registration timelines and communicate strategies with health authorities and stakeholders.

2. Maintain regulatory approvals throughout the product lifecycle using change controls; ensure regulatory activity efficiency by maintaining agreements with internal functions and external partners.

3. Understand, communicate, and implement evolving regulatory requirements and strategies within the organization, and develop innovative regulatory strategies to overcome obstacles and accelerate global approvals.

4. Cultivate and utilize relationships with key stakeholders; lead sophisticated initiatives, resolve organizational barriers, and negotiate win-win compromises to influence the current and future direction for Roche and its products.

5. Make sound decisions independently and courageously, even outside of comfort zones; embrace decision-making principles and troubleshoot issues, developing proactive and cost-effective solutions to maintain compliance.

6. Drive innovation across the organization, promote new ideas, and seize entrepreneurial opportunities; demonstrate VAAC leadership, foster an inclusive environment, and develop agile mindsets and behaviors.

7. Pull teams together around common goals, resolve conflicts by fostering openness and trust, articulate sophisticated ideas clearly, encourage honest discussions, actively participate and create recognition-filled environments.

Who you are

1. Second-level education and a Bachelor’s or Master’s degree in Life Science, Data Science, Regulatory Affairs, or a related subject, with advanced degrees considered an advantage. Equivalent experience or qualifications are also acceptable.

2. Demonstrated knowledge of Daily Management and Continuous Improvement best practices. Experience ranges from 3-8 years depending on the degree (Ph.D., Master’s, Bachelor’s) in fields like IVDs, Medical Devices, Pharma, Biopharmaceuticals, with significant experience in Regulatory Affairs.

3. In-depth knowledge of global regulatory requirements, guidelines, and procedures, especially for IVD instruments and software. Familiarity with European, US, China, and other international regulations and quality standards is an advantage.

4. Strong organizational and communication skills, the ability to multitask, handle multiple projects simultaneously, and work independently in a self-management environment.

5. Profound experience in Regulatory Affairs across various functions like R&D, Quality, and Clinical. Some business travel may be required.

Are you ready to apply? We want someone who thinks beyond the job offered – someone who knows that this position can be an outstanding opportunity to craft the future of Roche.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche Diagnostics International in Rotkreuz is a leading provider of diagnostic systems solutions, and the largest manufacturer of fully automated in vitro diagnostic systems in Switzerland. We are more than 2,700 passionate colleagues from over 65 nationalities. Find out more about our site in Central Switzerland, here .

Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.

We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.

Roche is an Equal Opportunity Employer.

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