Sr. RA Specialist, TW/HK

Job Title: Senior Regulatory Affairs Specialist

As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment.  The individual may execute tasks and exercise influence generally at the middle management level.  The individual may assist in the registration of products by preparing and submitting documentation needed for registration in Taiwan and Hong Kong.

• 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.

Masters or Bachelorâs degree (or equivalent) in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.

Minimum 5 years of experience in In-Vitro Diagnostics or Medical Device regulation in Taiwan and Hong Kong preferably.

Core Requirements:

Regulatory Knowledge/Skills

• 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

Communication

• 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.

Cognitive Skills

• 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

Leadership

• 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.