Danaher Corporation Regulatory Affairs and Quality Assurance Manager in Tokyo, Japan
SCIEX Job Description
Regulatory Affairs and Quality Assurance Manager
As a global leader in mass spectrometry, SCIEX delivers solutions for precision detection and quantification of molecules to help protect and advance the wellness and safety of all. Because of our 50 years of groundbreaking innovation, our customers can quickly respond to environmental hazards, better understand biomarkers relevant to disease, improve patient care in the clinic, bring relevant drugs to market faster, and keep food healthier and safer. At SCIEX, you’ll find a rewarding role that amplifies your impact on the world and helps you realize life’s potential.
SCIEX is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.
Location/Region: Tokyo Japan
Reports to: Manager, Global Regulatory Affairs
Essential Duties, Critical Success Factors, Responsibilities, Authorities and Required Interactions:
Act as General Manufacturing and Distribution Supervisor and Quality Control Manager of K.K. AB Sciex responsible for assuring products’ quality and safety.
Functions as the Japan Management Representative to ensure the K.K. AB Sciex Japan QMS is established, implemented and maintained in accordance with Japan Pharmaceutical Affairs Regulations.
Establishes and supports a work environment of continuous improvement that supports SCIEX’s Quality System and appropriate site regulations.
Responsible for maintaining the Quality and Compliance strategy for Japan.
Develops and maintains quality system metrics to ensure continuous improvement
Responsible for ensuring training for Quality Systems and Regulatory compliance areas under scope
Works closely with Global QARA, as well as key business partners to provide guidance and collaboration
Coordinate RAQA activities for K.K. AB Sciex with Global Regulatory Affairs, Quality Assurance and Legal Counsel teams to ensure the products’ quality and their compliance with regulatory requirements.
Prepares and confirms new medical device application forms.
Oversees the internal audit program at Sciex Japan and participates as the site QARA representative in external audits.
Prepares various applications compliant with the latest regulatory requirements.
Liaises with government authorities.
Confirms if the products are ready to market from the local regulatory compliance point.
Confirms if the labels on the products meet the local regulatory requirements.
Assures products’ quality.
Establishes, applies and manages GQP and GVP.
Ensures all marketing content and advertising meets the regulatory requirements.
Attends required RA seminars and conducts internal training for associates.
Performs other duties as assigned.
Education and/or Work Experience Requirements:
Obtain experiences and educational backgrounds meeting regulatory requirements to be a General Manufacturing and Distribution Supervisor and Quality Control Manager.
Extensive knowledge on medical device related laws and regulatory requirements.
Experiences on medical device sales application.
BS of science courses and experiences on experiment or instrumental analysis.
Business level of English communication.
Work experiences in Multi-National medical device companies.
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.
Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.
If you’ve ever wondered what’s within you, there’s no better time to find out.
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.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.If you’ve ever wondered what’s within you, there’s no better time to find out.