Regulatory Affairs Specialist, Japac

4 days ago

Sydney, Australia Masimo Full time

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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