Work with groundbreaking and innovative medical technology
Good salary-up options in a well-established global firm
The client is a global leader with a long-term commitment to providing reliable genomics and biotechnology solutions. The company innovates and develops quality diagnostics, reagents and assays with an aim to constantly set new standards in the industry, and currently has a strong share in most major markets already. With a well-established portfolio in Japan, the company harnesses their passion for innovation and invests heavily to the field of bioanalytics and gene editing.
- Assist in activities associated with regulatory approval of IVD medical devices in Japan.
- Assist in meeting and consultation activities to gain PMDA's feedback on study designs and other proposals.
- Assist in submission activities for a variety of device regulatory approvals.
- Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic and discipline as relevant to assigned projects.
- B.S./B.A. in a science, engineering, or related technical field.
- 2 years' experience in regulatory affairs. IVD industry is preferred.
- Strong organizational skills and attention to detail required.
- Collaborate with a diverse range of clients, partners and experts in the essential field of regulatory health care
- Boost English language ability through close strategy collaboration with global partners
- Demonstrate leadership and team playing abilities to help people and organisations go from idea to innovation faster