Senior RA Specialist

Senior RA Specialist

Key Responsibilities

• Develop and implement Japan regulatory strategies in partnership with Regulatory Affairs leadership.

• Support IVD registrations, regulatory submissions, and lifecycle maintenance.

• Represent Regulatory Affairs in product change assessments and change management activities.

• Collaborate cross-functionally with Operations, Development, and other teams.

• Liaise with regulatory authorities on regulatory matters.

• Coordinate with international and global teams to prepare registration documentation.

• Support submission strategies and documentation for external partners and third-party consultants.

• Monitor regulatory developments, assess regulatory changes, and communicate requirements.

• Participate in industry or regulatory associations as needed.

Position Requirements

• Bachelor’s degree or equivalent in Science, Engineering, Pharmacy, Life Sciences, or related field.

• Additional qualifications in project management or IT skills are a plus.

• Minimum 4 years of regulatory affairs experience, including IVD applications with PMDA.

• Experience with medical device notifications and applications.

• Knowledge of companion diagnostics regulatory submissions.

• Business-level English proficiency.

Other Qualifications

• Strong communication skills with internal and external stakeholders.

• Demonstrated potential for future managerial responsibilities.