At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting. Learn about the Danaher Business System which makes everything possible. The Regulatory Affairs - Senior Specialist is responsible for leading and executing regulatory project submissions and license management for high-growth markets within the region, driving continuous improvements and contributing to the success of the business for the organization. In Cepheid, learn about the available training opportunities for career growth and development, but also on personal learning available within Danaher Business system. This position is part of the Regulatory Affairs – Global Market Expansion Team and will be located in Singapore (Hybrid). At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions. In this role, you will have the opportunity to: Serve as a Regulatory Affairs lead on regional/SEA market expansion projects ranging from product registrations to renewals for assays, instruments, and software to support product launches. Prepare and review labels, and submission documents in compliance with in-country regulations and guidelines. Ensure filing, organization and maintenance of all documents and correspondence following Cepheid processes with a mindset for regulatory compliance and audits. Responsible for tracking, managing, and reporting regulatory project timelines and contributing to the development of registration schedules for on-time delivery of RA deliverables to complete registration plans using system tools, matrices, and bowlers. When necessary, identify possible project risks for escalation and review RA priorities as they relate to department and company goals and objectives. Win as a Team – interact and engage extensively with global cross-functional colleagues and external customers to maintain a productive and communicative relationship with your stakeholders to resolve submission queries or challenges. Serve as an in-country representative and subject matter expert: For regulatory intelligence - review and interpret new and revised regulations/guidelines for sharing; For product development - provide in-country regulatory requirements to the NPD core team, as needed. Be a mentor to junior associates and provide regulatory guidance to cross-functional teams. Implement continuous improvements and efficiencies using DBS tools and training materials. The essential requirements of the job include: Bachelor's Degree in Life Sciences or related fields Minimum 3 years of direct regulatory experience in the medical device or diagnostic industry, supporting at least 1 or more Southeast Asia countries or within the Asia-Pacific region. Ability to work independently and maintain a "focused urgency" throughout the submission process. Strong written and communication skills, and comfortable working in a dynamic multi-functional environment. Well-versed in MS Office and applications It would be a plus if you also possess previous experience in: Familiarity with Molecular Science or Polymerase Chain Reaction (PCR) based technology, or in diagnostics product development At Cepheid we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part of the time at the Company location identified above and part of the time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cepheid can provide. Wenn Sie sich uns anschließen, dann schließen Sie sich auch der globalen Organisation von Danaher an, der bereits 80.000 Menschen angehören, die jeden Tag mit dem Bestreben aufwachen, unsere Kunden beim Erreichen ihrer Ziele zu unterstützen. Als Mitarbeiter werden Sie Neues ausprobieren, hart arbeiten und Ihre Fähigkeiten mit der Hilfe engagierter Führungskräfte verbessern – stets mit der Unterstützung der leistungsstarken Tools des Danaher Business System und der Stabilität eines bewährten Unternehmens. Vielfalt und das Bestehen sowohl von Gleichheit als auch von Unterschiedlichkeit – ob sichtbar oder nicht – unter unseren Mitarbeitern, am Arbeitsplatz und auf den Märkten, die wir bedienen, sind uns bei Danaher sehr wichtig. Unsere Mitarbeiter, Kunden und Aktionäre leisten dank dieser unterschiedlichen Eigenschaften wichtige Beiträge mit eigenen und unterschiedlichen Perspektiven. Wenn Sie sich jemals gefragt haben, was in Ihnen steckt, ist dies die Gelegenheit, es herauszufinden. 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