(Assistant) Manager, Regulatory Affairs, APAC

Responsibilities

Oversee registrations and submissions of IVD in APAC and to be involved in clinical trials and evaluations for blood cancer markers
Analyze and interpret complex data
Offer general advice on regulatory strategy for new products and product changes
Recognize post market surveillance issues that require corrective action and reporting
Liaise directly with international regulatory agencies and provide supporting documentation, handle queries and issues

Contribute to the development and implementation of regulatory policies, procedures and specifications across the company and ensuring that these are compliant with the Quality System
Update on the progress of registration processes and other RA group activities to line management when requested.
Responsible for planning own workload and works with limited input from the line manager, influencing personal training and assisting in setting appropriate time lines for projects
Assist with the regulatory compliance of marketing communications/messages for the company products and services

Experience

A scientific, medical or engineering background - preferably with a degree or equivalent with some regulatory experience
Previous exposure to the regulatory submission process
Experience in Biology, healthcare or related disciplines
Experience of the IVD industry
ISO13485
Understanding of Good Clinical Practice in clinical trials
Bilingual in English and Mandarin to communicate with the Mandarin Speaking authorities

EA License no: 16S8066 | Registration no: R1550486

Only successful candidates will be notified.

(Assistant) Manager, Regulatory Affairs, APAC | Clinical Diagnostics MNC