Frieda Lin Email & Phone Number

台灣 臺北市 松山區

-Evaluate the changes and plan strategies for FDA 510(k) and Health Canada (MDL) for several types of products.-Evaluate the strategy of new submission in new market, such as GB, AU, EU etc and also coordinate with NB, AB, RP and local agents.-Applying the knowledge, such as ISO 13485 and MDSAP acquired to establish procedures and plan; Accumulated experience in TFDA (QMS) and third-party (ISO 13485 and MDSAP) audits.-Accumulated experience in medical device knowledge, such as ensure that the registration aligns with DHR (Device History Record) compliance, prepare the requirements for B2B local registration etc.-Involve the discussion for changes evaluation and risk assessment

台灣 新北市 汐止區

-Coordinate and communicate with CMC Team and prepare the package for IND submission-Ensure timely prepare and submit Annual report to FDA-Share regulatory requirements with team and involve in strategies of new product launch in several markets (TW/ASEAN/CA/US/AU/EU...)-Provide required regulatory supports for different product types and markets-GAP analysis on regulatory requirements of markets-Involve the discussion and preparation rick assessment, marketing research, competitor analysis, business development and project management

台灣 Taiwan 南投縣

- Communicating with global regulatory affairs personnel for registration requirements and technical support- Establish CTD dossier as per ICH guideline for EU/ASEAN/LATAM/US submission- ROW regulatory submission strategy advice and planning- Submission/variation deficiency letter management- Variation evaluating as per EU/US/ASEAN guidelines- Variation planning, variation submission pack established and variation submission to EU/US/ASEAN/LATAM countries- Implement regulatory strategies and required activities to ensure products launch- Maintain license databases and product master file

台灣 Taiwan 新竹縣

-Protein purification process of vaccine in the process development stage-Optimization of downstream purification process development to fit the technique transfer requirement to GMP manufacturing process-Contribute trouble-shooting in the purification processes-Manufacturing process improvement, e.g., Program optimization to deliver production efficiencies -Support the optimization plan on trial production, engineering run, validation studies and batch documentation management.