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Join us and make a difference too!\nRegulatory Lead\nJapan- home-based, with expected travel to the BSI Yokohama office and international travel on a needs basis\nAbout the role\nBSI Regulatory Services are looking for a Regulatory Lead who leads BSI in maintaining Registered Certification Body Status and PMDA Scheme in Japan - including Regulatory Intelligence, NC/OFI ownership, designated main liaison with the MHLW/PMDA, internal/external audit interface and reporting of any compliance concerns.\nResponsibilities:\nProvide regulatory input and expertise to the Operations Teams, e.g. Scheme Managers, QMS, Commercial\nOwn, update, and provide training on Japan specific procedures/forms in the BMS\nComplete reviews of external documents that impact on BSI’s QMS to include Regulatory Intelligence updates\nSupport/Deliver certification decisions and regulatory/confirmation letter approvals\nLead the external audit process and support the closure of all non-conformities raised during audits to ensure BSI continued operation as an Registered Certification Body\nAct as the primary interface for the internal audit and provide support as necessary\nLead on all change notifications to the MHLW/PMDA, as necessary\nLead and provide additional support (where necessary) the development and implementation of the necessary processes and procedures to ensure continuous compliance with registration/ designation/ accreditation requirements\nProvide advice to the business in the process of developing new and revised services and products taking cognizance of the risks to the business\nAct as the primary interface between the MHLW/PMDA and BSI\nLead and participate in process improvement projects, ensuring appropriate adherence to procedures and appropriate stakeholder involvement\nRepresent BSI in regulatory forums internally and externally - assume primary responsibility in attending the ARCB on behalf of BSI Japan\nTo be successful in the role, you will have:\nFirst or second degree in Engineering, Science, or related discipline\nNative level of Japanese, business fluency in English\nThorough understanding of technical documentation required by the manufacture of medical devices including the applicable regulations and standards\nThorough knowledge of Medical Device QMS standards and regulation\nA good understanding of the application of accreditation/designation, notified body, product and quality systems standards and requirements\nGood relationship building skills, with internal and external stakeholders\nBroad technical understanding of client industry products\nBSI offers a competitive total reward package, an independent and varied job in an international environment, flexible working hours, ongoing training and development with the inclusion of up to 14-days annual leave, paid sick leave, bank holidays, health insurance, life insurance, commuting allowance, paid maternity leave, paid paternity leave, paid parental leave, paid bereavement leave, learning and development opportunities, and a wide range of flexible benefits that you can tailor to suit your lifestyle.\n#LI-LH1 #LI-Remote\nAbout Us\nBSI is a business improvement and standards company and for over a century BSI has been recognized for having a positive impact on organizations and society, building trust and enhancing lives.\nToday BSI partners with more than 77,500 clients in 195 countries and engages with a 15,000 strong global community of experts, industry and consumer groups, organizations and governments.\nUtilizing its extensive expertise in key industry sectors - including automotive, aerospace, built environment, food and retail, and healthcare - BSI delivers on its purpose by helping its clients fulfil theirs.\nLiving by our core values of Client-Centricity, Agility, and Collaboration, BSI provides organizations with the confidence to grow by partnering with them to tackle society’s critical issues - from climate change to building trust in digital transformation and everything in between - to accelerate progress towards a better society and a sustainable world.\nBSI is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace.","description_format":"text","description_chars":4222,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"Japanese","level":"Proficiency (C2)","optional":false},{"language":"English","level":"Advanced (C1)","optional":false}]},"benefits":["Annual leave","Flexible schedule","Health insurance","Life insurance","Parental leave"],"hiring_locations":[{"name":"Japan","iso":"JP","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Management Consulting","Testing, Inspection & Certification","Standards & Industry Bodies"],"lifecycle":[{"event":"open","at":"2026-10-22T00:11:53Z"}],"visa":[],"liveness":{"score":9,"band":"cold","label":"Long shot","p_open":0.9,"p_active":0.367,"p_room":0.28,"age_days":197,"expected_fill_days":45,"reasons":["conf:49","stale_co","velocity","win:tail","crowd:brand"],"computed_at":"2026-10-24T06:02:35Z"},"pay":null,"html_url":"https://alion.io/job/bsi-group-regulatory-lead","json_url":"https://alion.io/job/bsi-group-regulatory-lead.json","meta":{"generated_at":"2026-10-24T17:32:31Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":25496,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-25T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":60307},"rest":"https://alion.io/mcp/rest/get_company?id=60307"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fbsi-group-regulatory-lead"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fbsi-group-regulatory-lead"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fbsi-group-regulatory-lead"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/bsi-group-regulatory-lead\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fbsi-group-regulatory-lead"}]}