Regulatory Affairs Specialist

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 Specialist is responsible for supporting and executing regulatory project submissions and license management for high-growth markets within the region, driving continuous improvements and contributing to the business's success 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 an assistant RA lead on regional/SEA market expansion projects ranging from product registrations to renewals for assays, instruments, and software to support product launches.
• Support and prepare 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.
• Work closely with RA lead to assist with active tracking and monitoring regulatory project timelines and contribute to the development of a registration schedule for on-time delivery of RA deliverables to complete registration plans using system tools, matrices, and bowlers. When necessary, highlight possible project risks to RA lead and adjust 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 - be a developing subject matter expert in regulatory intelligence and provide in-country regulatory requirements to the NPD core team in the product development stage, as needed.
• Develop skills in continuous improvement and project management using DBS tools and training materials.

The essential requirements of the job include:

• Bachelor’s degree in Life Sciences or related fields
• Minimum of 1 year experience in direct administrative regulatory role OR 2 years or more in allied support/operational role within the medical device or diagnostic industry.
• Fast learner, receptive to guidance and training, and maintain a sense of "focused urgency" in supporting submission projects.
• 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:

• Preference for familiarity and interest in medical sciences, or Polymerase Chain Reaction (PCR) based technology.
• Technical or operational-related departments within an IVD or medical device industry

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. When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful tools and the stability of a tested organization. At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes. If you’ve ever wondered what’s within you, there’s no better time to find out. #J-18808-Ljbffr