Regulatory Specialist Diagnostics

<p>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.</p><h3></h3><p></p><h3>The Position</h3><p><span style="color:#292a2e"><i>Relocation benefits <b>are not</b> available for this job posting.</i></span></p><br /><p><span style="color:#292a2e"><b>About this position:</b> Owns products from a RA perspective for the assigned area of responsibility.

Shall obtain Regulatory approvals in defined markets in close cooperation with other functions. The documents/deliverables for submissions are coordinated and compiled in a timely manner to support planned product registration timelines, and basic registration strategies are developed and communicated with Health Authorities and stakeholders. The obtained Regulatory approvals/ permits/licenses products are maintained throughout the life cycle of the product by applying successful Regulatory change controls.

The efficiency and the success of the Regulatory activities and strategies are maintained by clear agreements with other functions, stakeholders, and external partners (authorities, companies, NBs, etc.). The regulatory requirements and strategic aspects are understood, communicated and implemented, kept up to date and are transparent within the organization. The activities are driven by a mindset of innovation, agility, and the principles of VACC leadership.</span></p><br /><p><span style="color:#292a2e"><b>The Opportunity:</b></span></p><br /><ul><li>Oversee regulatory document and submission compilation by developing registration dossiers for moderately complex products/programs and managing comprehensive global regulatory submissions and registration plans.</li><li>Manage external interfaces and regulatory strategy by partnering with stakeholders to understand problems/opportunities, providing effective solutions, developing influential external relationships, contributing to audit preparation/execution/follow-up, and applying regulatory framework knowledge (e.g., IVDR) to create strategies for legally marketing Roche products/programs of simple-to-moderate regulatory complexity.</li><li>Build strong stakeholder relationships and influence effectively by understanding organizational relationships, roles, needs and responsibilities, applying appropriate stakeholder management, communicating timely and clearly, and maintaining effective, enduring partnerships.</li><li>Demonstrate sound decision-making and problem-solving with minimal supervision: complete daily activities accurately, present issues and solutions, gather relevant information, think through problems logically, identify options, make timely decisions, solve daily challenges, find agreeable stakeholder solutions, and escalate issues when needed.</li><li>Drive innovation, agility and VAAC leadership by generating new ideas, leveraging diverse perspectives, seeking new opportunities and approaches, living the “we all lead” mindset, acting with integrity/courage/passion, honoring commitments, supporting inclusion and diversity, embracing change, new technologies, data literacy, regulatory tools and continuous productivity improvements.</li><li>Contribute strong teamwork and communication by building collaborative relationships, sharing information/knowledge/guidance, participating in conflict resolution, listening actively, expressing ideas clearly, being truthful, remaining open to others’ input, and recognizing colleagues’ contributions.</li></ul><br /><p><span style="color:#292a2e"><b>Who you are:</b></span></p><br /><ul><li>University degree (Bachelor’s or Master’s) in Life Science, Biology, Biochemistry or Analytical Chemistry, Biotechnology or a related field. or equivalent experience which may include technician/laboratory technician training or comparable qualification with many years of relevant experience.</li><li>1–5 years of professional experience in Regulatory, R&D, Quality, Operations and/or Clinical Operations, with ability to manage moderately complex projects.</li><li>Work experience in lab diagnostics is preferred, including R&D, Clinical Trials, Quality Control or admission/Quality Management areas.</li><li>Strong IT skills, including MS Office, databases, and document management systems.</li><li>Fluent written and spoken English <br /></li></ul><p><b>Preferred

skills:

</b></p><br /><ul><li>Hands-on experience with IVD (In-vitro Diagnostics) or Medical Device regulations (EU IVDR 2017/746, US FDA 510(k)/PMA, etc.).</li><li>Exposure to process automation, robotic workflows (RPA), or AI-enabled regulatory tools.</li><li>Familiarity with international quality standards (e.g., ISO 13485)</li></ul><br /><p><span style="color:#292a2e"><i><b>Please note:</b> Resumes <b>must</b> be submitted in English, as our interview panel may include participants from outside your local country.</i></span></p><p><b> </b></p><p><b> </b></p><p></p><h3>Who we are</h3><p style="text-align:left">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.</p><p style="text-align:left"><br />Let’s build a healthier future, together.</p><p style="text-align:inherit"></p><p style="text-align:left"><b>Roche is an Equal Opportunity Employer.</b></p>