We are seeking an experienced Regulatory Affairs/Quality Assurance Manager to join our team in the newly established ‘IRhythm Japan’. This position provides an opportunity to be at the forefront of medical wearable and artificial intelligence technologies that are making a difference with patient outcomes and better healthcare.   

You will be responsible for the regulatory and quality activities for iRhythm Japan and will work closely with other regulatory and quality representatives at iRhythm’s global sites to ensure iRhythm maintains a robust and compliant regulatory and quality system and process. Additionally, this role is responsible for working directly with the Quality Management Representative to act as the delegate for the Management Representative locally. 

As the Quality and Regulatory department expands within Japan over time, this position will ensure the performance, coaching & development, and scaling of the function within the Japan site.

Responsibilities: 

• Responsible for product launch regulatory strategies and product change regulatory assessment for Japan.
• Author Japan submissions and closely working with the iRhythm US regulatory team to ensure timely Japan regulatory submissions & notifications.
• Ensure the overall Japan site activities are in compliance with iRhythm’s Quality System and applicable standards / regulations and meeting Japan MHLW/PMDA requirements
• Establishing capabilities for the site to act as the appropriate representatives per local regulation requirements if needed
• Lead local management of external audits, including Notified Bodies
• Execute the responsibilities of local Quality Management Representative, continuously assess the resolve regulatory compliance risks at the site
• Engages in continuous improvement activities by identifying opportunities and recommending improvements to processes across the Japan site.
• Managing activities with external regulatory or quality service companies (e.g., DMAH) to ensure Japan country regulatory compliance
• Aid in investigation of complex Japan site regulatory and quality issues
• Contribute to regulatory & quality department procedures to maintain and improve regulatory compliance
• Review and approve labeling, advertising, and promotional materials as needed.
• Support product health hazard evaluations, recalls and communications for internationally commercialized products.
• Monitors the regulatory landscape to anticipate and prepare for emerging regulatory obstacles; influence the regulatory landscape through partnerships with industry working groups, trade associations, and communications with regulatory agencies.

About you: 

Required:

• Bachelor’s Degree or equivalent quality/regulatory experience
• Minimum of 6 - 8 years of experience in Quality and/or Regulatory related role.
• Japan regulatory submission experience
• Expert knowledge of Japan medical device regulation
• AI/ML software as medical device experience highly preferred
• Direct exposure to regulatory body inspections and/or Notified Body audits.
• Medical device product development or sustaining/life cycle management experience.
• Strong interpersonal and relationship building skills and ability to work collaboratively.
• Exceptional communication (written and oral) skills in English
• Strong project management skills
• Exceptional problem-solving skills
• Exceptional organizational skills
• Willingness to travel when required, up to 10%

 Desirable:

• SaMD/MDSW, wearable, procedure pack and OTC medical device experience highly preferred
• Demonstrated understanding of ISO 13485, ISO 14971, ISO 10993, IEC 62304, IEC 62366, GDPR, HIPAA and other international regulations/directives/standards highly preferred

This is a full-time, remote working in Japan position. 

FLSA Status: Exempt

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