TITLE: Regulatory Affairs Manager, Japan
DEPARTMENT: Regulatory Affairs
REPORTS TO: Regulatory Affairs Director
LOCATION: Japan
The role
Biocomposites continues to experience dramatic growth, realising our mission to increase the number of patients we can help, by extending our market coverage in new specialities and new geographies. We are continuing to grow in international regions including Japan, and now have an exciting opportunity for a Japanese speaker to join our growing team.
The Regulatory Affairs Manager, Japan, will develop regulatory strategies and lead product registrations in Japan. They will work closely with multiple stakeholders including the Regulatory Affairs Director, Japanese consultants and PMDA.
What do we offer?
Competitive salary and benefits! With us, you will receive a competitive salary package and benefits.
We grow talent. At Biocomposites we create opportunities to thrive and grow.
One Biocomposites – team spirit & engagement. Our culture is important and we strive to create engaged and inclusive global teams that encourage colleagues to share their diverse perspectives and opinions.
Who do we look for?
People who are passionate about what we do.
People who are open minded to evolving the way we work.
People who can work together to transform outcomes and change lives.
REQUIRED EXPERIENCE:
- Bachelor’s Degree in a life science discipline or equivalent.
- Minimum 5 years’ experience within the medical device industry.
- Experience of pre-submission consultations with PMDA.
- Experience of medical device submissions to PMDA.
- Proven knowledge of medical device regulation and applicable standards and guidance documents in Japan.
- Knowledge of MDSAP audit program.
- Fully proficient in both Japanese and English (written and oral).
If you are interested please forward your CV and cover letter stating the position you are applying for to careers@biocomposites.com