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Jobs in Malaysia   »   Jobs in Pontian   »   Regulatory Affairs Executive

Regulatory Affairs Executive

Pontian, Johor, MY
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Job Description:   

  • Ensure that company’s products comply with the applicable regulations.
  • Maintain and update national and international legislation, guidelines and customer practices.
  • Collect, collate and evaluate scientific data from a range of sources.
  • Develop and write clear arguments and explanations for new product license as well as license renewal.
  • Prepare submission of license variations and renewal approvals.
  • Monitor and set timeline for license variations and renewal approvals.
  • Write clear, accessible product labels and instruction leaflets.
  • Involved in post-market surveillance reporting as guided by the Senior Group RA Manager.
  • Advise R&D team on regulatory requirements and regulatory strategy.
  • Undertake and manage regulatory inspections and technical documentation audit.
  • Maintaining the technical documentation and EU declaration of conformity together with Senior Group RA Manager.
  • Review company practices and provide advice on changes / improvement to the system.
  • Liaise with and make presentations to regulatory authorities.
  • Negotiate with regulatory authorities for marketing authorization.
  • Specify storage, labelling and packaging requirements.
  • Actively involved in company’s environmental initiatives.
  • Ensure that target agreed for the KPI’s under the responsibility of the position are achieved.
  • To ensure all other duties and projects as assigned by the superior are done.

Job Requirements:

  • Candidate must possess at least a Bachelor's Degree, Post Graduate Diploma, Professional Degree in Scientific Discipline.
  • At least 1 year of working experience in the field of medical devices and regulatory affairs on medical devices.
  • Required Language: Well versed in English, Bahasa Malaysia & Mandarin.
  • Analytical and problem solving skills.
  • Full time position available.
  • Applicants must be willing to work in Pontian, Johor.

Perks & Benefits

  • Allowance (phone, transportation, etc.)
  • Flexible working hours
  • Regular team activities
  • Medical insurance
  • Open culture

Job Location
Lot 2244, Batu 39 1/2, Pontian Besar, 82000 Pontian, Johor, Malaysia.
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Company Overview

Karex is the world’s largest manufacturer of condoms. As both a Malaysian and International success story, our products are exported to over 130 countries across Africa, Asia, America, Europe and the Middle-East. We produce more than 5 billion condoms annually – more than twice the size of our nearest competitor – and we are not stopping there. Our workforce of more than 3,000 employees based across Malaysia (Port Klang, Pontian and Senai)Thailand (Hat Yai & Bangkok), UK and US have helped us to become one of the highest performing companies listed on the Malaysian stock exchange.

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Company Summary
Karex
https://www.karex.com.my/
1001+ employees
Manufacturing / Production
Follow Karex
Job Openings
Total 2 jobs
Business Development Executive
Port Klang
Senior Creative Designer / Creative Designer
Port Klang

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