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Regulatory Lead
Japan- home-based, with expected travel to the BSI Yokohama office and international travel on a needs basis
About the role
BSI 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.
Responsibilities:
- Provide regulatory input and expertise to the Operations Teams, e.g. Scheme Managers, QMS, Commercial
- Own, update, and provide training on Japan specific procedures/forms in the BMS
- Complete reviews of external documents that impact on BSI’s QMS to include Regulatory Intelligence updates
- Support/Deliver certification decisions and regulatory/confirmation letter approvals
- Lead 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
- Act as the primary interface for the internal audit and provide support as necessary
- Lead on all change notifications to the MHLW/PMDA, as necessary
- Lead 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
- Provide advice to the business in the process of developing new and revised services and products taking cognizance of the risks to the business
- Act as the primary interface between the MHLW/PMDA and BSI
- Lead and participate in process improvement projects, ensuring appropriate adherence to procedures and appropriate stakeholder involvement
- Represent BSI in regulatory forums internally and externally – assume primary responsibility in attending the ARCB on behalf of BSI Japan
To be successful in the role, you will have:
- First or second degree in Engineering, Science, or related discipline
- Native level of Japanese, business fluency in English
- Thorough understanding of technical documentation required by the manufacture of medical devices including the applicable regulations and standards
- Thorough knowledge of Medical Device QMS standards and regulation
- A good understanding of the application of accreditation/designation, notified body, product and quality systems standards and requirements
- Good relationship building skills, with internal and external stakeholders
- Broad technical understanding of client industry products
BSI 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.
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About Us
BSI 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.
Today 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.
Utilizing 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.
Living 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.
BSI is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace.
Skills Required
- First or second degree in Engineering, Science, or related discipline
- Native level of Japanese, business fluency in English
- Thorough understanding of technical documentation for medical devices
- Knowledge of Medical Device QMS standards and regulation
- Good relationship building skills with stakeholders
BSI Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about BSI and has not been reviewed or approved by BSI.
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Flexible Benefits — Flexible benefits are positioned as part of the MyReward approach, allowing tailoring based on local eligibility and individual needs. Core elements like life assurance, income protection, and EAP access are framed as consistent pillars even as specifics vary by country.
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Leave & Time Off Breadth — Leave offerings are described as generous in certain markets, including annual leave starting around 27 days where that is standard and, in some U.S. postings, about four weeks of PTO plus a set holiday calendar. Additional time-off practices like occasional year-end office closure are also described as part of the overall package in some teams.
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Wellbeing & Lifestyle Benefits — Well-being support is presented as visible at the corporate level, including EAP access and expanded programs such as menopause support and mental-health first aid. Flexible work under “Smart Working” is repeatedly positioned as a work–life balance and inclusion lever that complements the total rewards package.
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What We Do
BSI is your business improvement partner. We have shaped best practice for over 100 years, partnering with organizations to accelerate progress and create impact for a fairer society and sustainable world
