Job Location:
Japan
Medical Device Regulatory Affairs Expert
Requested Languages:
OR
We are a service provider company, leader in the Pharmaceutical and Medical Device sectors. With more than 900 employees and 26 subsidiaries all over the world (Europe, Asia and the Americas), joining PQE means to join a multicultural and challenging company in which you will be involved in international projects, working with colleagues from all over the world.
Due to our constant growth and new projects in Japan, we are looking for a Medical Devices Regulatory Affairs Expert.
- Local legal entity registration
- Transfer ownership of existing product licenses from the current company to new one, per project plans
- Submit and gain approval for company name change for all products, per project plans
- Complete all activities to gain new product approvals and product changes:
- Identify reportability for changes and regulatory strategy for new products
- Prepare new product or product change submissions, based on EU or US product submission materials
- PMDA advisory meetings
- Manage deficiency responses, working with legal manufacturer
- Communicate updates with legal manufacturer
- Ensure proper IFU and product labels
- Review and approve promotional material
- Provide regulatory guidance on over-labeling by local office
- Ensure license renewals and maintain license documentation
- Support MDSAP audit preparation by collecting documents and responding to questions
- Monitor and communicate changes in local regulations and impact
- Availability for twice/month meetings, aligned with EU time
RESPONSIBILITIES
- Degree in technical discipline
EDUCATION:
- Native Japanese speaker with a professional knowledge of English
- Expertise in local regulations
- Proven ability to work with minimal supervision
- Proven ability to recommend strategic plans for regulatory approvals
- Proven success with executing regulator meetings
REQUIREMENTS:
- +5 years’ experience in Regulatory Affairs, Consultancy or Medical Device industry
EXPERIENCE REQUIRED:
Full-Time Job
If interested, please send your resume in English, clicking on "Apply Now" button on this page.
Our collaborators are engaged, developed, challenged and well-rewarded for performance. We recognize the importance of leadership at all levels of our organization in order to succeed in a challenging business environment, and we are committed to providing practical processes and programs to identify, develop and inspire all our current and future leaders.
