安全責任者（Sr. Quality Assurance Specialist)

Mozarc Medical seeks a self-motivated, highly experienced quality and regulatory affairs individual to join the Japan Quality Assurance team. This role is a key leader collaborating with and advising the APAC regional team relative to establishing and maintaining our products and services in markets in the region. This individual will report directly into the Sr Manager, Quality Systems – Japan and work in close partnership with Regulatory Affairs team, the Japan regional leadership team, and the global quality management team.

We are seeking a qualified Quality leader with experience and ability to manage the Anseki (also known as An-Seki or Safety Controller) responsibilities to ensure compliance with Japanese regulatory requirements and maintain global quality standards. The preferred candidate will extensive knowledge of and/or experience regarding all regulations in in Japan.

Role of the Sr Quality Assurance Specialist, Japan:

• Plan, direct, and implement all quality activities for Mozarc products and services within the Japan Region, acting as the Anseki, or Safety Controller of Medical Devices, ensuring consistent, timely, and effective post market controls. Representing the organization as the Anseki within Japan for all in-country quality matters.
• Assuring appropriate product quality monitoring and reporting by executing in-country quality activities, such complaint management, reportability decisions and regulatory reporting, field corrective action planning and execution, risk assessment, interfacing with customers, and liaising with PMDA and responding directly to queries.
• Partnering closely with the global Mozarc Quality organization to establish and meet enterprise Key Process Indicators (KPI); plan, deploy, and execute global processes.
• Acting as the Japan Quality Subject Matter Expert - source of coaching and guidance for leaders, peers, and subordinates. Partnering closely with the Sokatsu, or General Marketing Supervisor Medical Devices, and the Hinseki, or Domestic Quality Assurance Manager.

Key Accountabilities:

• Provide leadership within the Japan Quality function; support and execute the Japan Quality strategy, act as Subject Matter Expert for Quality in region, and coach, train, and mentor peers and team member.
• Responsible for safety team and safety controlling activities
• Monitor safety controlling activities and generate necessary records
• Report and escalate issues related to safety controls
• Collaborate with global post-market surveillance team
• Establish effective communication with the Japanese health authorities (e.g., PMDA).
• Ensure compliance to policies and procedures. State the opinion in writing to top management and responsible officers when deemed necessary to perform the activities appropriately and while being compliant with regulations.
• Facilitate the collaborations between the department of quality or manufacturing controls and the department of safety controls. Provide information or give instruction to manufacturers, foreign registered manufacturers, distributors and medical institutions as necessary for the purposes of domestic safety controlling activities.

• Partner to ensure the appropriate safety controls monitoring the performance and quality of products in the field to conform to established company standards necessary to maintain lasting consumer satisfaction.
• Responsible for the activities for safety controls. Ensure that domestic operations for safety controls are executed appropriately and smoothly. Ensure product quality within the Japan region by assuring the necessary safety and post market controls.
• Collect the information on the product quality (including defective and potentially defective products) in the country and from overseas. Report them to leadership so that necessary and appropriate actions shall be taken and relevant records shall be created.
• Interface with internal partners, customers, and regulatory bodies regarding product complaints, vigilance reporting, and product recalls.
• Ensure that regulatory activities are consistent with local regulatory authority requirements.
• Facilitate regulatory inspections by authorized Body auditors or local regulatory authorities.
• Review government policy changes with regards the regulatory function and develops policy position papers and advocacy to support the interests of the organization with regards policy development.
• Ensure that the Company’s agreed quality standards (including ISO13485) are maintained with regard to its products, procedures, policies, operations and customer contact.

Requirements

• Minimum undergraduate degree (e.g., Bachelor of Science, Bachelor of Arts), preferably in engineering or sciences
• Three (3) years of relevant experience with 1 year of leadership experience, or advanced degree (e.g., Masters, PhD) with a minimum of 1 years of relevant experience with 1 year of leadership experience.
• Sound understanding of and experience with GVP ordinance, .

Relevant Experience and Knowledge

• Experience and in-depth knowledge of the Japan Region and international Medical Devices regulations, including ISO13485 and MDSAP. Experience communicating and partnering with PMDA regarding product safety.
  • Preferred qualified or registered as Anseki
• Required 2+ years in a role working in Japan region, preferably with experience in multiple countries, languages, and cultures.
• Good communication channel with regulatory body and industry working groups.
• Demonstrated strong people leadership skills and experience.
• Strong project management skills and ability to deliver under tight deadlines and pressure.
• Experience across multiple products and/or geographies
• Sound understanding of and experience with the management of Quality systems, QMS ordinance, ISO13485.
• Excellent verbal and written English communication and interpersonal skills.

Attributes

• Patient focused
• Systematic and detail minded
• Self-motivated and positive
• Responds to deadlines and priorities
• Aptitude for technology
• Empathetic, good listener - gives recognition where it's due
• Resilient, persistent

Working Environment/ Conditions

• Some domestic and overseas travel may be required
• Some out of hours work will be required (e.g., working in partnership with Americas and EU)
• Hybrid work environment (e.g., in office and remote)
• Full time remote candidates may be considered, but preference may be given to candidates near or able to attend to the office in central Tokyo.