Regulatory Affairs Manager (m/f/d)

Regulatory Affairs Manager (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

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 mindset 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 excellence, we invite you to be part of our dedicated team.

Qualifications

• Bachelor’s Degree in Life Sciences, Regulatory Affairs, or a related field

• Profound experience in Regulatory Affairs; several years preferred in Regulatory, R&D, Quality, and/or Clinical, with some experience in Healthcare regulatory affairs

• In-depth knowledge of global regulatory requirements, guidelines, and procedures especially for IVD instruments & software

• Strong organizational and communication skills

• Ability to multitask and effectively manage multiple projects simultaneously

• Self-motivated and capable of working independently in a self-management environment

Key Responsibilities

• Leading and supporting regulatory strategies for global product submissions

• Ensuring compliance with international regulatory requirements and standards

• Collaborating with cross-functional teams, including R&D, Quality, and Clinical, to drive regulatory initiatives

• Providing regulatory guidance to support product development and lifecycle management

• Staying abreast of evolving regulatory trends and up‐ dates, and implementing best practices

If you are a dedicated professional who thrives in a fast-paced environment and is passionate about contributing to the International Regulatory Affairs landscape, we want to hear from you! Submit your resume and cover letter detailing your relevant experience and qualifications.

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.