We are seeking an experienced Regulatory Affairs Specialist to lead and manage regulatory activities in Japan, supporting the importation, registration, and distribution of medical devices in compliance with local regulations. This is a pivotal role that ensures the organization’s continued success in the Japanese market by maintaining regulatory compliance and building strong relationships with internal teams and government authorities.
Key Responsibilities:
Prepare, review, and submit regulatory applications to PMDA/MHLW, including pre-market notifications, marketing approvals, and change notifications.
Manage local product registration activities for medical devices to ensure accurate and timely submissions.
Maintain and update all regulatory approvals/licenses in response to regulatory changes.
Coordinate with MAH and D-MAH entities to ensure continued legal and regulatory compliance.
Support QMS conformity assessments, including foreign site inspections and renewals under MHLW Ordinance No. 169.
Collaborate with Quality, Clinical, R&D, and Supply Chain teams on product launches, labeling, and post-market surveillance.
Monitor and interpret new/revised regulations, guidelines, and standards to assess impact on company products and operations.
Act as the regulatory point of contact during audits, inspections, and communications with PMDA/MHLW.
Provide strategic regulatory input during product development and localization stages.
Requirements:
Experience & Skills:
5–7 years of hands-on experience in Regulatory Affairs within the medical device industry in Japan.
Deep knowledge of Japanese regulatory frameworks, including the Pharmaceutical and Medical Device Act (PMD Act), STED format, and MHLW/PMDA guidelines.
Proven track record of successful PMDA submissions and direct communication with regulatory authorities.
Familiarity with Class II–IV medical devices, including SaMD and combination products (preferred therapeutic areas: cardiopulmonary, cardiovascular, or neurosurgery).
Fluent in Japanese and proficient in English (TOEIC 830+ or equivalent).
Strong organizational skills with the ability to manage multiple projects in a fast-paced environment.
Education:
Bachelor’s degree or higher in Life Sciences, Engineering, Pharmacy, or a related field.
Work Environment:
This is a Tokyo-based role with occasional domestic travel as required. Flexible working options may be available depending on business needs.