Director of Regulatory Affairs and Quality Assurance

Position Location
JP-Tokyo

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As a new generation medical device company, we believe in the power of working together to make a meaningful and positive difference. Applied Medical is committed to improving the accessibility and affordability of high-quality healthcare globally. We achieve this through a vertically integrated business model that enables our team members to develop technologies that enhance clinical care, while offering boundless opportunities for professional growth. We are dedicated to creating an environment where team members of diverse backgrounds are valued, challenged and acknowledged.  Applied Medical’s products have been serving the Japanese market for over 20 years. In order to continue to build sustainable Japanese partnerships so we can serve the evolving needs of the Japanese health system, we are investing in hiring Regulatory and Quality team members. 

Position Description

The Director of Regulatory Affairs and Quality Assurance will be responsible for overseeing and ensuring compliance to RA, QS and QA requirements in Japan for Applied Medical products.  The person in this role will also be expected to develop the local regulatory and quality system strategies and to implement plans according to the pre-defined timelines to support company objectives.  The Director of RA and QA may manage and/or provide input into the department’s overall budget and oversees and manages RAQA staff resources and/or outsourced RAQA services.

 

Essential duties

  • Develop and implement the local regulatory strategies in compliance with Japanese regulations
  • Provide regulatory and quality support as needed to Distributors and/or DMAHs and 3PLs
  • Perform supplier and/or economic operator audits as needed following MDSAP
  • Design and execute a local Quality Management System compliant with Japan, US, EU and worldwide GMP standards
  • Lead and support RAQA effort to prepare, submit and manage regulatory facility inspections/audits to obtain marketing authorization approval, manufacturer registrations, QMS certificates and other necessary approvals
  • Ensure all local investigations are performed and closed in a timely fashion
  • Monitor and report adverse events, recalls and other required post market surveillance regulations
  • Provide guidance, interpretation, support, training and input on the interpretation and implementation of regulations, guidelines and SOPs
  • Review, monitor and approve documentation, as assigned, to ensure compliance with relevant standards, regulations and guidance documents
  • Maintain regulatory and quality expertise in the changing regulatory environment
  • Interacts with internal team members, external partners and regulators to resolve regulatory matters ranging from pending application negotiations to proposed legislation and guidance document ramification for the business
  • Hire, train and mentor new RAQA team members as well as complete performance reviews
  • Prepare and conduct the Quality Management Review meetings with senior management
  • Advise executive management on external environment and strategic compliance trend impacting our business
  • Involve with providing input and overseeing the RAQA budget in Japan
  • Perform additional duties and responsibilities as required by leadership

 

Other duties and responsibilities

  • Continue to foster the growth of team members by selecting, organizing and developing training opportunities
  • Manage training initiatives to ensure Applied Medical internal stakeholders understand applicable Japanese regulations and proactive collaboration with cross-functional team members to meet established objectives
  • Be recognized, both internally and externally, as the Applied Medical Japan contact person in Japanese regulatory and quality affairs
  • Build necessary relationships with internal and external stakeholders
  • Cooperates closely with global regulatory colleagues and create systems to facilitate more efficient support of new registrations, change management, renewals and post-market surveillance and reporting worldwide

Position Requirements

Position qualifications

Knowledge, skills and abilities

  • Qualified to become Sokatu Seizo Hanbai Sekininshya

-With degree of physics, chemistry, metal, electric, engineering, mechanical, information, biology, pharmacy, medical or dental

-Minimum 5 year of experience in quality assurance or safety control

-Completed lecture by MHW

  • Proficient in performing audits, root cause investigations, and CAPAs
  • Knowledgeable in PMD Act, ISO 13485, ISO 14971 (required); knowledgeable in ISO 60601 (preferred)
  • Ability to work independently and as part of a team
  • Analytical, meticulous and detail oriented
  • Assertive and not afraid to ask questions
  • Effective oral and written communication and presentation skills in both Japanese and English
  • Friendly, good attitude, customer service oriented
  • Able to multi-task, organize and prioritize
  • Ability to appropriately interpret existing and emerging regulations, standards or guidance documents including potential impact on regulatory and quality functions
  • Strong technical writing skills
  • Effective leadership, mentoring and guidance skills
  • Consultative leadership style
  • Ability to travel, as required
  • Fluent in English and Japanese – speaking ability at level to participate in global working groups or English TOEIC score above 750 points

 

Education

4-year college degree or equivalent degree of physics, chemistry, metal, electric, engineering, mechanic, information, biology, pharmacy, medical or dental

 

Experience

 

Minimum 8 years of working in a combination of QA, SA, and RA role and/or overseeing team members in these roles.

Benefits

Applied offers benefits package following Japanese labor laws

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