At Cepheid, we improve healthcare through fast, accurate diagnostic testing. Our mission drives us to develop scalable, groundbreaking solutions to 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. 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 works 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.
The Regulatory Affairs Senior Specialist is responsible for leading and executing Cepheid regulatory submissions and license management in Japan, and to manage and support in-country clinical trial activities, drive continuous improvements, and contribute to the success of the business for the organization.
This position is part of the Regulatory Affairs – Global Market Expansion Team and will be located in Japan (Hybrid), reporting to Cepheid's Manager, Regulatory Affairs, Global Market Expansion and the legal entity for this role is under Beckman Coulter DX Japan. 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 dedicated lead for Japan projects ranging from product registration, change filing to license renewal for assays, instruments, and software to support Cepheid product launch, with the opportunity available to support regional regulatory market projects as part of market expansion team.
- Prepare and review labels, submission documents in compliance with in-country regulations and guidelines. Ensure filing, organization and maintenance of all documents and correspondence in accordance with manufacturer processes and a mindset for regulatory compliance and audits.
- Responsible for tracking, managing, and reporting product registration timelines and contribute to development of registration schedule 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.
- Lead in-country clinical trials for IVD registration and manage activities with clinical sites and/or commercial laboratories or partners when required.
- Maintenance of licenses of IVD/MD manufacturing sites
- Win as a Team – Provide regulatory guidance to cross-functional teams, 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 query 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 NPD core team, as needed.
- Implement continuous improvements and efficiencies using DBS tools and training materials.
The essential requirements of the job include:
- Bachelor's degree and/or above, in Life Sciences or related fields.
- 3 or more years of direct regulatory experience for Class 1, 2, 3 medical device or diagnostic industry, supporting Notification/Certification/Approval process.
- Deep knowledge of PMD Act and related regulations; ie Industrial Safety and Health Act, Poisons and Deleterious Substances Control Act, Chemical Substances Control Act, Act against Unjustifiable Premiums and Misleading Representations, Promotion Code
- Experience to develop the registration strategy through the discussion and negotiation with Health Authority., with ability to work independently and maintain a "focused urgency" throughout the submission process.
- Experience managing in-country clinical trials with clinical sites and/or commercial laboratories.
- Intermediate proficiency in English, and well versed in Microsoft office and applications.
- Strong written and communication skills, and comfortable to work in a dynamic multi-functional environment, and in a matrix organization.
It would be a plus if you also possess previous experience in:
- Preference for familiarity with molecular science, or Polymerase Chain Reaction (PCR) based technology, or in diagnostics product development.
- Technical or operational related departments within an IVD or medical device industry is highly preferred.
Danaher, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at https://www.danaher.com/careers/benefits.
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