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

Job details

Location: Singapore
Job Type: Permanent
Discipline:
Reference: HCLS/EP/AMRAAPAC/13
Posted: 5 months ago
Consultant: Ewen Poh
Consultant Email: email Ewen
Consultant Phone: +65 6950 0365

Job description

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.

 

This job has expired!