position overview
Job Location : Japan , Tokyo - 23 Wards
Job Type: Permanent Full-time ( remote)
We are searching for an experienced Regulatory Affairs Specialist in Medical Devices for our office in Japan. The successful candidate should have at least three years’ experience in Regulatory Affairs with Medical Devices and has submitted and has interacted with PMDA in previous occasions. The RA specialist will support compiling and registering medical devices with PMDA with the supervision of the RA Manager.
RESPONSIBILITIES
- Monitor and guide the organization to improve in compliance with the latest J-PMD Law and related ordinances / regulations required for Medical Device and MAH （Manufacturing Authorization Holder）.
- Participate in and facilitate cross functional team for new product introduction to provide expertise in regulatory strategies.
- Research assesses and/or consult to identify on regulatory requirements to register new or changed products.
- Assess and/or consult to identify on QMS requirements to register new or changed products.
- Develop strategies and plans to register and/or launch assigned product and execute by
- coordinating internal and external stakeholders to complete its registration.
- Administer communication with the regulators to support their review of our regulatory applications.
- Monitor the progress of the preparation and review status by the local team outsource and regulator to update the international team and management at regular basis.
- Lead and consult preparation execution of reimbursements application.
- Monitor and assess regulatory impacts of new and revised regulations guidance and standard.
- Review and approve new and revision of design manufacturing input from the manufacturers suppliers to ensure the compliance along with Japanese regulatory requirements.
- Draft revise review consult and/or approve labelling to ensure the compliance to corporates requirement Japanese regulations.
- Review and/or approve labelling to ensure they are documented and produced in compliance to domestic internal requirements on QMS
- Register and maintain QMS Accreditation of medical devices IVDs.
- Register and maintain MAH manufacturing Repairing Distribution and other licenses necessary for local distributor of the products.
- Monitor and assist improvement of compliances of the organization per regulatory requirements including those for Repairing Distribution of Medical Device and/or IVD.
- Support QA team by providing regulatory insights to support creation and update of use/user’s manual PMS reporting and field actions.
- Participate in maintenance and improvement of regulatory and development processes to support compliances.
REQUIRED QUALIFICATIONS
- 3 years or more of experience in regulatory affairs for medical devices above class 2
- Experience with communication with PMDA or notified body reviewers.
- Good communication skills in English （written and oral）
- Sufficient PC skills to administer regulatory datasets and their revisions ・Excellent team player Preferred
- Knowledge and experiences on Surgical Devices
- Experience on pre submission consultation with PMDA
- Experience to have participated in registration project with international stakeholders.
- Experience or knowledge on QMS Accreditation and ISO 13485 requirements
- 3 yrs. or more of experiences as one or more of representative of Medical Device MAH （Sokatsu Hinseki or Anseki）
- Facilitator
- Good analytical and problem-solving skill
- Self-motivator and self-learner
GENERAL REQUIREMENTS:
- Minimum Experience Level: 3-year
- Career Level: Mid-Career
- Minimum English Level: Daily Conversation
- Minimum Japanese Level: Native
- Minimum Education Level: Bachelor’s Degree
- Visa Status: Permission to work in Japan required
- Age Limit: (No Age limit for applicants) 応募者の年齢制限なし