Job Summary

Company Name
Charterhouse Pte Ltd

Locations
Singapore

Experience
3 - 10 years

Key Skills
Regulatory Affairs,Medical Devices

Education
Bachelors/ Degree

Function
Pharmaceutical/ Biotechnology

Role
Other Pharma

Industry
Pharmaceutical

Posted On
13th Jun 2018





About Us

Charterhouse is an Australian owned executive recruitment consultancy, which has expanded its operations in Singapore in mid 2006. Charterhouse was formed by bringing together a number of the industry's most successful, experienced and professional, permanent and contracting recruitment consultants. By merging their vast, international experience the vision was to create a business built upon not just meeting expectations but consistently exceeding them, through dedication, passion and integrity. Charterhouse offers specialist services within the Accounting, Banking & Finance, Sales and Marketing, Technology, Industrial, Manufacturing and Engineering fields. 4 Battery Road Bank of China Building #33-01 SINGAPORE 049908 Tel: 65 6435 5600 Fax: 65 6438 1600 Email: apply@charterhouse.com.sg Website: www.charterhouse.com.sg Agency License Number: 06C3997

Job Title

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

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 


Please contact Ewen Poh at +65 6435 5616 or charterhousehealthcare@charterhouse.com.sg for a confidential discussion

EA License no: 16S8066 | Registration no: R1550486

Only successful candidates will be notified.

 

Powered by Monster