Lead regulatory strategy and compliance for innovative medical devices in a dynamic, global organization. You will be responsible for overseeing all aspects of regulatory affairs for assigned products, ensuring timely and successful submissions to Japanese regulatory agencies. You’ll collaborate with cross-functional teams, providing expert guidance on regulatory compliance and strategic planning. You will also monitor global regulatory changes, proactively identifying and mitigating potential risks. This role offers a unique opportunity to influence product development and contribute to the success of life-saving medical technologies.
業務内容:
Lead regulatory strategy and compliance for innovative medical devices in a dynamic, global organization
Prepare and manage regulatory submissions to Japanese agencies (e.g., IDE’s, PDMA, PMA’s, annual reports, 510(k)’s, STED’s, CE marking)
Represent regulatory affairs on product development and manufacturing teams
Develop and implement regulatory strategic plans
Monitor global regulations and assess their impact on projects
Review promotional materials and labeling for compliance
Provide guidance on regulatory requirements for strategic planning
応募資格:
Bachelor's degree in a scientific discipline (e.g., Biology, Microbiology, Chemistry) or related field
5+ years of experience in regulatory affairs within the medical device industry
Proven expertise in preparing and submitting regulatory documentation to Japanese agencies
Deep understanding of Japanese regulations for medical devices (Class I-IV)
Excellent written and verbal communication skills in English and Japanese
Strong problem-solving, analytical, and critical thinking skills
Experience working effectively in cross-functional teams
Experience in leading and mentoring team members is highly desired
