Regulatory Affairs Specialist / Regulatory Affairs Specialist
|職種||Regulatory Affairs Specialist|
|社名||Regulatory Affairs Specialist|
As a member of R Q MA team in HOLOGIC Japan Regulatory Affairs Specialist takes the responsibility in regulatory affairs to;
Acquire and maintain regulatory permissions to market medical products with primary focus on gynaecological surgery breast health and infection disease diagnostics.
Cooperate with the team to maintain and improve regulatory and QMS compliances and to permeate throughout the organization.
Monitor and guide the organization to improve in compliance with the latest J PMD Law and related ordinances / regulations required for Medical Device MAH （Manufacturing Authorization Holder）.
Participate in and facilitate cross functional team for new product introduction to provide expertise in regulatory strategies.
Research assess 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.
If capable and quaified represent MAH manufacturing of Medical Device and/or IVD as one of its administrative officers such as Sokatsu Hinseki Anseki etc. of a Medical Device and/or IVD.
Monitor and as
・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
・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）
・Good analytical and problem solving skill
・Self motivator and self learner
|年収||600万円 - 900万円|