BQ Lead Japan | WSA Japan

Driven by the passion to improve quality of people’s lives, WSA continues to grow as a market leader in the hearing aid industry. With our commitment to increase penetration in an underserved hearing care market, we want to accelerate our business transformation in order to reach more people, more effectively.

Are you an experienced Quality and Regulatory Affairs leader in the medical device industry, ready to make a meaningful impact on quality, compliance, and patient safety?

Join WSA Japan as BQ Lead Japan, where you will lead the country’s Quality Management System (QMS) and regulatory activities, ensuring compliance with ISO 13485, Japan’s Pharmaceuticals and Medical Devices Act (PMD Act), and global corporate standards. As the Management Representative and Marketing Authorization Holder (MAH) for WSA Japan, you will play a pivotal role in maintaining regulatory compliance, strengthening quality standards, and enabling business growth across manufacturing, sales, distribution, and wholesale operations.

Working closely with local, APAC, and global stakeholders, you will drive continuous improvement, build a strong quality culture, and ensure our products and operations meet the highest standards of quality and regulatory compliance.

What you will do

• Lead the implementation, maintenance, and continuous improvement of the local Quality Management System (QMS) in accordance with ISO 13485, Japan’s PMD Act, and corporate requirements

• Oversee regulatory affairs, including medical device registration, product approvals, facility licensing, certifications, technical documentation, labeling, and regulatory inspections

• Act as the Management Representative and Marketing Authorization Holder (MAH) for WSA Japan, serving as the authorized representative for applicable medical device regulatory matters

• Establish and manage internal audit programs and coordinate external audits and inspections, ensuring effective control of documentation, non-conformances, CAPA, change management, and training

• Provide quality assurance support across manufacturing, sales, distribution, wholesale, and service operations, including product introductions, product transfers, product release, and complaint management

• Lead and develop the local BQ team while partnering with cross-functional and global stakeholders to assess quality risks, drive root cause analysis, and implement corrective and preventive actions.

What you bring

• Significant experience in Quality Assurance, Quality Management, or Regulatory Affairs within the medical device industry, with strong knowledge of QMS and regulatory compliance

• Hands-on expertise in ISO 13485 and Japan’s PMD Act, including product registration, regulatory submissions, and medical device regulatory requirements

• Proven experience managing regulatory inspections, internal and external audits, and quality processes across manufacturing, sales, distribution, or service operations

• Demonstrated leadership capabilities, with experience developing teams and influencing stakeholders across functions in a multinational environment

• University degree in Engineering or an equivalent field; a background in Electronics is preferred. QMS or ISO 13485 Auditor certification is required, while Six Sigma certification or relevant knowledge is an advantage

• Native-level Japanese and advanced business-level English proficiency, with the ability to engage confidently in APAC and global discussions. A proactive, hands-on, collaborative, and business-oriented mindset is essential, balancing regulatory requirements with customer and business needs.

Who we are

At WSA, we provide innovative hearing aids and hearing health services.

Together with our 12,000 colleagues in 130 countries, we invite you to help unlock human potential by bringing back hearing for millions of people around the world.

With us, you will become part of a truly global company where we care for one another, welcome diversity and celebrate our successes.

Sounds wonderful? We can't wait to hear from you.

WSA is an equal-opportunity employer and committed to creating an inclusive employee experience for all. Regardless of race, color, religion, national origin, age, sex, gender, gender identity, gender expression, sexual orientation, marital status, medical condition, ancestry, disability, military or veteran status we firmly believe that our work is at its best when everyone feels free to be their most authentic self.