GENERAL SUMMARY
Provide regulatory affairs services to ensure the new products or life-cycle management products received regulatory approvals with a timely manner both IVD (ClassIIand ClassIII) and medical device (ClassI and ClassII) by hands-on communication with MHLW and PMDA. Furthermore, GVP standpoints, to ensure that monitoring internal or external events related to product and to provide the necessity pharmacovigilance report to local governance by compying with local regulations, industry and OpCo standards. May develop, maintain, monitor for GVP procedure or SOP/WI etc.
May cooperate with audit and inspection preparation, resolution of audit and inspection findings with QA. May have frequent interaction with other functional areas and operating entities.
Mainly responsible for regulatory affairs for both IVD and medical device Class 2 & % of daily work should be contributed with planning for regulatory strategy/gap analysis for the purpose of STED submission and query resolution from PMDA until market authorization in Japan. As GVP role (Anseki) 4030% would be contributed with regular monitoring for pharmacovigilance detection, assessment, understainding and prevention of adverse effects or any other IVD/medical device related problems.
Major RESPONSIBILITIES
- Both IVD and medical device MAH GVP responsible person(Anseki).
- Both IVD and medical device MAH regulatory affirs responsible for life-cycle management.
- May support for collaborating with BU and SU stakeholders to manage quality issues including support for the administration of fileld actions (Recall) and reporting in complaint system.
- To update GVP documents based on local regulation modification/new release.
- May lead regular internal GVP meeting, if necessary.
- May support all related LBS license (MAH IVD/medical device, poisonous substance import,medical device maintanance etc.)
- To lead medical writing regarding both IVD and medical device STED.
- To lead PMDA consultation document preparation and preparation for answers of queries from PMDA.
REQUIREMENTS FOR THIS POSITION
a) Professional Experience
- Minimum of 7 years' work experience in medical or life science market.
- >5 years People Management experience (Preferred).
- Effective communication skills in English and a client service orientation.
- Excellent cross functional communication skills.
- Strong business acumen in understanding commercial aspect of healthcare business.
- Organized individual with strong self and project management disciplines, including the ability to lead, facilitate, influence and organize across groups and according to timelines.
- Knowledge of MS Excel, Word, PowerPoint for business presentation and knowledge of PMDA DTD system will be highly advantageous.
b) Education
- Graduate from the Pharmacy Course of University or higher level majored in Pharmacy (Preferred).
C) Languages
- Japanese – Native
- English – speaking/listening intermediate, reading/writing advanced.
d) Travel (required estimated % of time)
- <10%
At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit
At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
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