Regulatory Affairs Specialist II

カテゴリー 薬事/品質
Job Locations JP-Tokyo

仕事の詳細

The RAQA Specialist II will be responsible for providing regulatory and quality support to meet company goals.  This includes ensuring compliance to RA, QS and QA requirements in Japan for Applied Medical products.  The person in this role will also be expected to contribute to the development of the local regulatory and quality system strategies and to implement plans according to the pre-defined timelines to support company objectives.

 

Essential duties

  • Compile documentation to support obtaining Marketing Authorization for Class 1 to 3 medical devices, including providing responses to address inquiries from any government agencies and notified bodies
  • Compile documentation to support minor/partial changes for Class 1 to 3 medical devices
  • Compile documentation to support Manufacturer Registration (domestic and foreign)
  • Compile and submit documentation as needed relating to reimbursement of medical devices
  • Support RAQA effort to prepare, submit and manage regulatory facility inspections/audits to obtain marketing authorization, manufacturer registrations, QMS certificates and other necessary approvals
  • Provide regulatory and quality support to MAHs of Applied Medical products, Distributors and 3PL as needed
  • Contribute to the development and implementation of the local regulatory strategies in compliance with Japanese regulations
  • Perform or support supplier and/or economic operator audits as needed following MDSAP
  • Contribute to the development of a local Quality Management System compliant with Japan regulation
  • Support the processes for customer complaints and feedback in Japan as needed
  • Monitor, prepare, and support compliance to adverse events reports, 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 evolving regulatory environment
  • Interact 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
  • Prepare and participate in Quality Management Review meetings with senior management
  • Involve with providing input to the RAQA budget in Japan
  • Perform additional duties and responsibilities as required by leadership

 

Other duties and responsibilities

  • Participate in the selection and training of new RAQA team members in Japan
  • 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
  • Build necessary relationships with internal and external stakeholders
  • Cooperate and contribute to the continuous process improvements and/or solution development and implementation to facilitate more efficient support to meet regulatory and quality requirements

職種要件

Position qualifications

Knowledge, skills and abilities

  • Effective in obtaining and maintaining Marketing Authorizations for Class 1 to 3 medical devices, including change management
  • Competent in managing the Manufacturer Registrations
  • Competent in supporting QMS on-site and document audits
  • 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 600 points

Education

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

 

Experience

 

Minimum 6 years of working in a combination of QA, SA, and RA role with a minimum of 4 years in regulatory submission

利点

  • Training and mentorship with ongoing learning and development courses
  • On-campus wellness activities
  • Comprehensive medical and dental and vision coverage
  • Education reimbursement program
  • 401(k) program with discretionary employer match
  • Generous vacation accrual and paid holiday schedule

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