Regulatory Innovation & Sustainment Professional - Quality and Compliance

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

Join Roche Product Development Regulatory Affairs (PDR), a flexible, bold, and distinctive regulatory organization where we make strategic decisions quickly, innovate boldly, and deliver insights that shape our portfolio development. We are seeking a talented professional to help build, mature, and sustain our regulatory business capabilities while fostering a culture of continuous learning and meaningful impact for patients.

The Opportunity:

• Support complex and higher exposure quality and compliance activities, providing guidance and risk assessment to PDR staff on GCP, GVP, MDR, and IVDR compliance issues, and serving as advisor and subject matter expert for Quality and Compliance-related processes

• Lead deviation management and process management activities, updating and maintaining regulatory documents while sustaining Quality and Compliance operational activities required for maintaining Roche's license to operate and Quality Management System (QMS)

• Oversee training management, scheduling training sessions and ensuring completion across PDR to support our commitment to regulatory compliance and continuous learning

• Prepare and manage compliance reports, monitoring trends in the external compliance environment

• Partner across the enterprise with stakeholders within and beyond PDR (including affiliates, PD quality organizations, and the broader Roche group) to unlock company-wide benefits and ensure regulatory compliance

• Lead increasingly complex deliverables while collaborating cross-functionally with key stakeholders, generating insights, and mentoring peers to foster a culture of innovation and continuous improvement

• Monitor and respond to trends in innovation and the external compliance environment, anticipating changes in the regulatory landscape and assessing future business needs

• Contribute to initiatives that shape our technical, business, and healthcare environments, bringing new ideas into the business and leading them with entrepreneurial mindset

Who You Are:

• 5+ years of relevant regulatory affairs, quality, or compliance experience in the Pharma or Medical Device space, with a proven ability to independently deliver and lead increasingly complex projects and initiatives

• Experience working with health authorities, understanding the global regulatory environment

• Strategic and systems thinker with strong data management, content management, and knowledge management capabilities; experienced in change leadership and operating effectively in matrix environments

• Cross-functional collaboration expert with demonstrated experience in building trusted partnerships across internal and external stakeholders, including health authorities

• Compliance-focused professional with a deep understanding of the global regulatory environment, GCP, GVP, MDR, and IVDR requirements, and a commitment to maintaining license to operate and integrity

• Continuous learner with a growth mindset, strong communication skills, and ability to seek and act on feedback

In exchange we provide you with:

• Development opportunities: Roche is rich in learning resources. We provide constant development opportunities, free language courses & training, the possibility of international assignments, internal position changes and the chance to shape your own career.

• Excellent benefits: Competitive salary and cafeteria package, annual bonus, Private Medical Services, Employee Assistance Program, All You Can Move Sportpass, coaching / mentoring opportunity, buddy program, team buildings, holiday party.

• Flexibility: We also support flexibility to help you find your balance. Home office is commonly available (typically 2 office days/week on average).

• A global inclusive community, where we learn from each other. At Roche, we cooperate, debate, make decisions, celebrate successes and have fun as a team. Our leadership is very focused on people, creating a strong, inclusive culture, so you always have the chance to share your opinion.

Please read the Data Privacy Notice for further information about how we handle your personal data related to the recruitment process: https://go.roche.com/budapest-data-privacy-notice-candidate

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.