JOB DESCRIPTION:

RESPONSIBILITIES:

  • Initiate NPI submission strategy, planning (MHLW, TUV, WHO, others)
  • Develops registration plans for assigned products in collaboration with regional Regulatory Affairs based staff and manufacturing site cross functional colleagues (QA, Supply Chain, Operations, etc)
  • Maintain also drive licensing (ISO13485, Japan-GMP, etc.) tasks together with QRC team
  • Participate design change project and provide the status update to cross functional colleagues (R&D, TechSupport, QA, Supply Chain, Operations, etc)
  • Ensures execution of registrations of products in alignment with regulatory plans
  • Maintain RA database such as GRID to Keep the most latest RA status
  • Actively participates in short and long-range planning including the development of Key Performance Indicators
  • Promotes awareness of regulatory and customer requirements throughout the organization, including through organized training programmed
  • Directly manages registration activities with Notified Bodies in Europe and the WHO
  • Supports sites in contact with National Regulatory Agencies
  • Represents manufacturing site as RA SME at relevant leadership meetings
  • Represents manufacturing site as RA SME in relevant Industry forums
  • Supports business operations in adverse event reporting
  • Supporting business operations in product modification reporting
  • Facilitates gathering of regulatory intelligence
  • Upholds the company’s core values

BASIC QUALIFICATIONS | EDUCATION:

  • BSc or equivalent.
  • Training in Regulatory Affairs
  • Relevant experience at a senior level
  • A minimum of 8 years’ experience in areas directly relevant to the position

PREFERRED QUALIFICATIONS:

  • Advanced understanding of compliance, cGMP and product development.
  • Able to prepare, analyze and present Key Performance Indicators (KPIs).
  • Process Excellence certified (Yellow Belt/Green Belt).
  • Analytical/Problem Solving Skills (e.g. DMAIC, statistical techniques, risk analysis)
  • Excellent written and oral communication skills with ability to interact with all levels leader-ship,  internal/external customers and third-party vendors.
  • Experience in rapid diagnostics industry

COMPETENCIES:

  • Ability to develop and manage high performing teams to achieve desired outcomes.
  • Demonstrated capacity to successfully execute strategies designed to achieve an appropriate return on investment for the business.
  • Demonstrable working knowledge of the medical diagnostics industry.
  • Understanding of Quality and Quality Management systems (ISO 13485, ISO 9001 and US FDA QSR)
  • Knowledge of the requirements of industry regulators.
  • Knowledge of emerging markets regulatory environment.
  • Capacity to apply sound judgement for the effective management of the company’s resources and personnel.
  • Capacity to identify strategic opportunities and recognise threats.
  • Excellent written and oral communication skills in English and an ability to prepare competent business cases.
  • Strong mission orientation.
  • Attention to detail.
  • Strong interpersonal skills.
  • Highest levels of integrity and diplomacy.
  • Capacity to maintain the highest levels of confidentiality internally and externally.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

JOB FAMILY:

Regulatory Operations

DIVISION:

ARDx Abbott Rapid Diagnostics

LOCATION:

Japan > Matsudo-shi : 357 Matsuhidai

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable

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