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.