Regulatory Affairs Consultant

1 week ago

Irvine, United States ALKU Full time

Japanese Regulatory Affairs SME


Job Summary:


We are seeking an experienced and highly knowledgeable Medical Device Regulatory Affairs Consultant with expertise in Japanese medical device regulations. The ideal candidate must be fluent in Japanese and possess in-depth knowledge of Japanese regulatory requirements (PMDA) as well as having direct experience writing authorized rep submissions. This role is critical in ensuring compliance with Japanese regulations for critical care cardiac monitoring devices, particularly those incorporating software and AI elements. The consultant will be responsible for gathering reports, reviewing protocols, and updating submissions to meet Japanese standards, while also working directly with international notified bodies and licensed representatives in the region.


Key Responsibilities:

  1. Japanese Regulatory Compliance: Serve as the subject matter expert on Japanese medical device regulations and ensure that all products and submissions comply with Japanese standards.
  2. Fluent Japanese Communication: Effectively communicate in Japanese with regulatory authorities, notified bodies, and licensed representatives to facilitate compliance and approval processes.
  3. Product Assessment: Assess critical care cardiac monitoring devices, with a strong focus on software and AI components, to ensure compliance with Japanese regulatory requirements.
  4. Documentation and Submission: Prepare, review, and update regulatory documents and submissions specific to the Japanese market, ensuring alignment with local standards.
  5. Notified Body Coordination: Collaborate with international notified bodies to address regulatory inquiries and ensure that products meet both Japanese and international standards.
  6. Licensed Representative Collaboration: Work closely with licensed representatives in Japan to navigate the local regulatory landscape and maintain compliance.
  7. Regulatory Strategy: Develop and execute regulatory strategies specific to the Japanese market, aiming for timely approvals and compliance maintenance.
  8. Regulatory Intelligence: Stay abreast of changes and updates to Japanese medical device regulations, providing proactive guidance to internal teams.
  9. Risk Management: Identify and mitigate regulatory risks associated with product development and changes, proactively addressing potential issues.
  10. Cross-Functional Collaboration: Collaborate with internal teams, including R&D, Quality Assurance, and Legal, to ensure regulatory requirements are integrated into the product development process.


Qualifications:

  • A minimum of 5 years of experience in medical device regulatory affairs, with a specific focus on Japanese regulations.
  • Fluent in Japanese, with the ability to effectively communicate and negotiate with Japanese regulatory authorities.
  • In-depth knowledge of Japanese regulatory requirements and standards for medical devices.
  • Strong familiarity with software and AI medical device regulations.
  • Proven experience in preparing and updating regulatory submissions for the Japanese market.
  • Excellent communication skills and the ability to work seamlessly within cross-functional teams.
  • Strong analytical and problem-solving abilities, with keen attention to detail.
  • Regularly updated knowledge of current trends and developments in Japanese medical device regulations.
  • Regulatory affairs certifications and memberships in relevant professional organizations (e.g., RAPS) are a plus

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