[Remote] Regulatory Affairs Expert ~ Medical Device

Work set-up: 
Full Remote
Contract: 
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Offer summary

Qualifications:

Proficiency in native-level Japanese and English., Experience in regulatory affairs for medical devices, especially Class III and IV., Knowledge of regulatory strategies, planning, and execution for new medical devices., Experience with IVDs and SaMDs is a plus..

Key responsibilities:

  • Develop and implement regulatory strategies for medical devices and IVDs.
  • Manage product registration processes with internal teams and authorities.
  • Serve as Japan regulatory SME and support business growth.
  • Train teams and ensure compliance with Japan's regulatory requirements.

Morunda | Pharmaceutical | Medical Device Recruiting | Japan (JPAC) Asia (APAC) logo
Morunda | Pharmaceutical | Medical Device Recruiting | Japan (JPAC) Asia (APAC) Human Resources, Staffing & Recruiting TPE https://www.morunda.com/
11 - 50 Employees
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Job description

Lead the development and implementation of regulatory strategies for Class III and IV medical devices and IVDs. Specialized in identifying opportunities, delivering effective regulatory solutions, and ensuring timely project execution

  • Plan and implement regulatory strategies for Class III/IV medical devices, IVDs, and SaMDs.
  • Manage end-to-end product registration with internal teams, consultants, and health authorities.
  • Deliver regulatory projects and solutions across regional client portfolios.
  • Support proposal development and project evaluations (e.g., RFPs).
  • Serve as Japan regulatory SME for medical devices; IVD/SaMD expertise preferred.
  • Scale operations to support multiple projects and clients efficiently.
  • Train internal teams, especially India-based staff, on document preparation in English.
  • Set up robust translation processes for Japan regulatory submissions.
  • Review and submit regulatory documents; follow up with Japanese authorities until approval.
  • Monitor Japan's regulatory changes and support business growth initiatives.



Requirements
  • Proficiency (speaking and writing) in Language: Good command in native-level Japanese and English.
  • Experience in Medical Device, with experience in a global regulatory affairs role including regulatory strategy, planning and execution for the new devices in the country.
  • Exposure or experience in QMS & Vigilance is plus point.
  • Good experience in Class III and Class IV Medical devices. The same for IVDs is desired.
  • Experience and/or Exposure with SaMD would be an additional advantage.


Required profile

Experience

Industry :
Human Resources, Staffing & Recruiting
Spoken language(s):
JapaneseEnglish
Check out the description to know which languages are mandatory.

Other Skills

  • Training And Development
  • Communication

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