regulatory affairs, senior executive -johor in Kuala Lumpur

posted
contact
joanne kurian, randstad
job type
permanent

job details

posted
location
kuala lumpur, wilayah persekutuan
specialism
manufacturing
job type
permanent
working hours
Full-Time
reference number
91M0146598_1594264291
contact
joanne kurian, randstad
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job description

We are urgently looking for a Senior Regulatory Affairs Executive for an international Medical Device company that focuses in surgical equipments.They have established their footprint here in Malaysia as well as across the globe.Over the past years they have been doing extremely well and have been increasing their market share by double digit.

Location: Johor

Reporting to: Chief Technical Officer
Travel : Malaysia & Singapore

the role

As a Senior Regulatory Affairs Executive you will have the opportunity to learn and obtain knowlege in doing product registarion as well as learn different laws across the region. Key aspects of this role include:

  • Develop and execute regulatory plans for complex projects including new products and maintenance of existing certifications.
  • Represent or lead the RA function on assigned cross-functional project teams.
  • Proficient in EN ISO 13485:2016 QMS Standard Requirement for Medical Devices.
  • Conduct audits on Medical Device Quality System based on ISO 9001, ISO 13485 and other associated regulatory requirements

the requirements

  • Bachelor degree in Biology, BioTechnology, Engineering (Bioengineering/Biomedical) or equivalent.
  • Minimum 3 years of experience in a medical device regulatory role and involved with reviewing technical documentation, compliance reviews, registration and conducting audits
  • Must have good knowledge in ISO 13485, ISO 9001, Medical Device directive and medical devices legislation (MDR and etc).
  • Experience with overseas regulatory standards such as US FDA, CE, HSA (Singapore) etc will be an advantage

To apply, click here to capture your full CV and details in one easy application to capture details with us for future vacancies. Or write to Joanne Kurian at joanne.kurian@randstad.com.my

Joanne Kurian
consultant - medical device & life science


Randstad Malaysia
Level 22.2, The Gardens North Tower
Mid Valley City Kuala Lumpur 59200
M +6018 275 6169
joanne.kurian@randstad.com.my
www.randstad.com.my




skills

no additional skills required

qualification

no additional qualifications required

educational requirements

Bachelor Degree