Sr. RA Specialist, TW/HK

• Manage the preparation and review of dossiers for new product registrations, product renewals, change notifications and other relevant applications as per local requirements in Taiwan & Hong Kong.
• Prioritize assignments and implement regulatory plans to achieve company objectives.
• Work collaboratively with internal cross-functional teams and external stakeholders (eg regulators) to deliver timely regulatory submissions and approvals.
• Provides prompt and accurate regulatory assessments for planned product changes based on local product change notification requirements.
• Support the management of all registration related documentations in Regulatory Information Management System (RIMS) throughout the product lifecycle.
• Prompt review and approvals of product labels/artworks and promotional marketing materials to ensure they are compliant to current internal process and local regulations.
• Foster seamless communications with relevant internal and external stakeholders on regulatory matters related to Abbott MDx products.
• Represent Abbott MDx in internal RAC meetings and external industry meetings.
• Monitor new and revised local Medical Device/IVD laws, regulations, standards, guidance documents etc. Communicate on their impact assessments and any risk mitigations to Global Regulatory and other relevant internal stakeholders.
• Support internal and external audits and follow up on any regulatory affairs related action items.

• Regulatory history, guidelines, policies, standards, practices, requirements and precedents
• Regulatory agency structure, processes and key personnel
• Principles and requirements of applicable product laws
• Submission/registration types and requirements
• Principles and requirements of promotion, advertising and labeling
• Domestic and international regulatory guidelines, policies and regulations
• Ethical guidelines of the regulatory profession, clinical research and regulatory process

• Communicate effectively verbally and in writing
• Communicate with diverse audiences and personnel
• Write and edit technical documents
• Work with cross-functional teams
• Negotiate internally
• May interact with vendors.

• Create project plans and timelines
• Exercise judgement within generally defined procedures and practices
• Strong attention to detail
• Handle detailed tasks and prioritize them
• Meet deadlines
• Think analytically and critically
• Review and analyze documentation
• Research and locate information on regulatory requirements and products
• Has general knowledge of technical alternatives and gain an understanding of their impact on the systems environment
• Apply business ethical standards

• Establishes and cultivates an extensive network of support to facilitate completion of assignments.

• Provide guidance to less experienced staff.
• May lead a RA project team.
• Participates in determining goals and objectives for projects.
• Influences middle management on technical or business solutions.

Abbott