regulatory affairs manager in Kuala Lumpur

posted
contact
joanne kurian, randstad
job type
permanent
salary
RM 12,000 - RM 18,000 per month

job details

posted
location
kuala lumpur, wilayah persekutuan
specialism
sales & marketing
job type
permanent
working hours
Full-Time
salary
RM 12,000 - RM 18,000 per month
reference number
91M0142901_1584334758
contact
joanne kurian, randstad
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job description

Our client is a reputable MNC organization in the Medical Device arena, with a presence globally. Their extensive New Product devekopement has brought them to be one of the leading Medical Device organization. They are looking for a Regulatory Affairs Manager to be part of their company to advance the company in compliance and goverment affairs.

Location : Kuala Lumpur

Reporting to: Head of Regulatory Affairs

Excellent Remuneration Package and Company Benefits

the role

  • Monitor regulatory submission, plan vs. actual to enable smooth business with no disruption and communicate with stakeholders on progress.
  • Build regulatory strategy and plan product registration, communicate with local distributor and local country team to complete registrations for existing products and new expansion of product portfolio.
  • Recommend responses and negotiate on queries with health authorities.
  • Review submission files with local country team and/distributor and engaging the global Regulatory team in resolving technical and documentation gaps for local registration process.
  • Oversee license renewals by working in close collaboration with commercial team along with SEA distributors and local country team

the requirement

  • Minimum of 5 years of relevant work experience in Regulatory Affairs in medical device and diagnostics.
  • Posses a Bachelor degree in Pharmacy.
  • Understanding of ISO 13485 and GDPMD is advantageous.
  • Track record in communicating with Regulatory Agencies.

in return

Excellent salary plus benefits, bonus and daily allowances, Excellent career exposure to work with the leading experts and product base in the market, job security and experienced team. If you have these desirable experiences and skills and are looking for a new challenge, please register your expression of interest to Joanne Kurian.

joanne.kurian@randstad.com.my

​Joanne Kurian

consultant - medical device & healthcare




skills

no additional skills required

qualification

no additional qualifications required

educational requirements

Bachelor Degree