regulatory affairs specialist in Singapore

posted
contact
johari masod, randstad
job type
permanent
salary
S$ 60,000 - S$ 70,000 per year

job details

posted
location
singapore
specialism
life science
job type
permanent
working hours
Full-Time
salary
S$ 60,000 - S$ 70,000 per year
experience
3 years
reference number
91M0135178_1561455395
contact
johari masod, randstad

job description

about the company

A principal brand owner with products sold in over 100 companies worldwide. They are leader for dental products globally and their looking for a Regulatory Affairs Specialist to support their rapid expansion in Asia.

about the job

  • Responsible for regulatory activities in SE Asia: regulatory submissions, compliance for new/ existing products
  • Assist in registration plans for new products, variations, modifications, registration renewals
  • Assist in collecting and analysing regulatory intelligence, and incorporate regulatory trends into decision-making processes
  • Supporting the product labelling with local regulations
  • Provide post market regulatory support and guidance as required
  • Follow up product license renewal

about the manager/team

An individual contributor, you will be reporting to the Regulatory Affairs Manager but you will have the opportunity to work with numerous internal and external stakeholders.


skills & experience required

  • Degree / Diploma in Life Sciences, Engineering or related discipline
  • At least 3 years of related working experience, preferably in the medical device / pharmaceutical / life sciences industry
  • Possess good knowledge of regulations and requirements for medical devices, GDPMDS (Good Distribution Practice for Medical Devices), EU Medical Device Directive/ Regulation, US FDA guidance, ISO standards (13485, 9001)


To apply online, please click on the appropriate link. Alternatively, please contact Johari Masod on +65 6510 3651 quoting Ref No. 91M0135178

EA: 94C3609 / R1109554



skills

regulatory affairs, ISO standards (13485, 9001)

qualification

Degree in Medical, Science or Engineering

educational requirements

Bachelor Degree