Regulatory Affairs Specialist, JAPAC

13 hours ago

Sydney, New South Wales, Australia Masimo Full time $104,000 - $130,878 per year

Job Description
Key Responsibilities

  • Prepare, submit, and manage regulatory filings for product registrations, renewals, and variations across JAPAC markets.
  • Monitor and interpret regional regulatory requirements to ensure ongoing product compliance and timely updates.
  • Collaborate with cross-functional teams (R&D, Quality, Marketing, and Commercial) to support product launches and changes.
  • Communicate with regulatory agencies and local partners to address queries and facilitate approvals.
  • Maintain regulatory documentation and records in accordance with internal policies and external regulations.
  • Support audits and inspections by regulatory authorities, ensuring readiness and timely response.
  • Track and report on regulatory submission status and emerging requirements to internal stakeholders.

Qualifications

  • Bachelor's degree in Life Sciences, Pharmacy, Engineering, or a related field.
  • 2–4 years of regulatory affairs experience in medical devices, diagnostics, or healthcare products, preferably within JAPAC.
  • Familiarity with regional regulatory frameworks (e.g., PMDA, TGA, NMPA, HSA, MFDS).
  • Experience preparing and managing regulatory submissions and supporting product registrations.
  • Strong written and verbal communication skills in English; proficiency in Japanese or other APAC languages a plus.

Skills & Attributes

  • Detail-oriented and organized, with strong documentation and record-keeping skills.
  • Analytical and proactive, able to interpret complex regulations and anticipate changes.
  • Effective communicator with the ability to collaborate across cultures and functions.
  • Problem-solver with a focus on compliance and continuous improvement.
  • Adaptable and resilient, thriving in a dynamic, fast-paced environment.

Join us — where innovation meets compassion, and your work helps shape the future of patient care.

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