Career Details

Regulatory Affairs & Quality Assurance (Medical/Scientific instrument)
Closing Date : 04 Jan 2019

  • Industry: Medical/Lifesciences
  • Location: West/Central

Descriptions:
  • Evaluate regulatory risks of Department policies, processes, procedures
  • Develop new regulatory policies, processes and SOPs in Department Business and train key personnel on them
  • Compile, prepare, review and submit regulatory submission to authorities
  • Monitor impact of changing regulations on submission strategies and update internal stakeholders
  • Oversee processes involved with maintaining annual licenses, registrations, listings and patent information
  • Ensure compliance with product marketing approval requirements
  • Review and approve advertising and promotional items to ensure regulatory compliance and ensure external communications meet regulations in Department Business
  • Provide regulatory input for product recalls and recall communications
  • Responsible for the preparation of documents for internal and external audits
  • Assist management in the monitoring of implementation of the regulatory system; legal and compliance issues.
  • Distributor Agreements Management, including timely renewal.
  • Coordinate and implement ISO system and standards required

Requirements:
  • Bachelor’s Degree
  • Min. 3 years of working experience in Regulatory Affairs field
  • Knowledge of Medical and/or Industrial Device regulations
All Successful candidates can expect a very competitive remuneration package and a comprehensive range of benefits.
Please submit your updated resume in Word format by using the Apply Now Button.

We regret that only shortlisted candidates will be notified
Email resume to gary.ho@peopleprofilers.com

People Profilers Pte Ltd, No. 1 Finlayson Green #18-01 Singapore 049246. Tel:  6589 5808 Fax:  6536 7890
http://www.peopleprofilers.com

EA Licence Number: 02C4944
Registration Number: R1549767
Posting Personnel: Gary Ho Cheng Xuan
 
Specialization : Sciences / Laboratory / R&D
Type of Employment : Permanent
Minimum Experience : 3 Years
Work Location : SINGAPORE
  

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