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Position Summary:
We are seeking an experienced Regulatory Specialist to lead and manage regulatory activities for Japan, supporting the importation and distribution of medical devices in compliance with Japanese regulations. The ideal candidate will have a minimum of 5–7 years of hands-on regulatory affairs experience, with in-depth knowledge of PMDA and MHLW requirements, including Class II–IV medical device submissions, STED dossiers, and QMS conformity assessments.
This role will serve as a key regulatory liaison with internal teams and Japanese authorities and will ensure ongoing compliance throughout the product lifecycle.
General Responsibilities:
- Prepare, review, and submit regulatory applications to PMDA/MHLW, including pre-market notifications, approvals, and change notifications.
- Oversee local registration activities for medical devices imported and distributed in Japan, ensuring timely and accurate submissions.
- Maintain and update regulatory approvals and licenses in accordance with local regulatory changes.
- Coordinate with MAH (Marketing Authorization Holder) and D-MAH entities to support legal and regulatory compliance.
- Support QMS conformity assessments, including foreign manufacturing site inspections and renewals under MHLW ordinance No. 169.
- Collaborate with cross-functional teams including Quality, Clinical, R&D, and Supply Chain to support product launches, labeling, and post-market surveillance activities.
- Monitor and interpret new or revised Japanese regulations, guidance, and standards to assess the impact on company products and processes.
- Act as the regulatory point of contact during audits, inspections, and with PMDA/MHLW reviewers.
- Provide strategic regulatory input during product development and localization phases.
Skills and Experience:
- 5–7 years of experience in regulatory affairs within the medical device industry in Japan.
- Strong knowledge of Japanese medical device regulations, including Pharmaceutical and Medical Device Act (PMD Act), STED format, and MHLW/PMDA guidelines, etc.
- Proven experience with PMDA submissions and direct communication with regulatory authorities.
- Familiarity with registration pathways for Class II–IV devices, including SaMD and/or combination products is a plus (preferred experience: engagement from document preparation to the closure of technical review by the regulatory authorities in the therapeutic area of cardiopulmonary, cardiovascular, or neurosurgery).
- Fluent in Japanese and proficient in English (spoken and written) with TOEIC score more than 830 or other certifications equivalent to.
- Highly organized, detail-oriented, and able to manage multiple projects simultaneously.
Education:
- Bachelor’s degree or higher in life sciences, engineering, pharmacy, or a related discipline.
Valuing different backgrounds:
LivaNova values equality and diversity. We are committed to ensuring that our recruitment process is fair, transparent and free from unlawful discrimination. Our selection process is driven by the key demands/requirements for the role rather than bias or discrimination on the basis of a candidate’s sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification.
Notice to third party agencies:
Please note that we do not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Services Agreement, we will not consider, or agree to, payment of any referral compensation or recruiter fee. In the event that a recruiter or agency submits a resume or candidate without a previously signed agreement, we explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.
Beware of Job Scams:
Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons posing as LivaNova recruiters or employees. The scammers may attempt to solicit confidential, personal information, such as a social security number, or your financial information. LivaNova will never ask for fees prior/during/after the application process, nor will we ask for banking details or personal financial information in return for the assurance of employment. If you are concerned that an offer of employment might be a scam or that the recruiter is not legitimate, please verify by searching for “See Open Jobs” on https://www.livanova.com/en-us/careers, and check that all recruitment emails come from an @livanova.com email address.
