- 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
- 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
- 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.