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Jobs in Singapore   »   Jobs in Singapore   »   Art / Design / Entertainment Job   »   Regional Regulatory Affairs Manager (Medical Device / Up to 8K)
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Regional Regulatory Affairs Manager (Medical Device / Up to 8K)

Integrity Partners Pte. Ltd.

Integrity Partners Pte. Ltd. company logo

Partnering with a global Medical Device MNC with an established branding, our client is seeking a Regional Regulatory Affairs Manager to join their team in Singapore.


Responsibilities

  • Responsible for regulatory activities across Southeast Asia - regulatory submissions, compliance for new or existing products
  • Support ANZ RA team on regulatory related activities for their region
  • Manage registration plans for new products, variations, modifications, registration renewals
  • Analyse registration complexity and provide regulatory advice to internal groups to support company’s business objectives
  • Collect and analyse regulatory intelligence, and incorporate regulatory trends into decision-making processes
  • Approval of product labelling with local regulations
  • Maintain awareness of regulatory requirements or changes
  • Provide post market regulatory support and guidance as required
  • Follow up on product license renewal
  • Any other ad-hoc duties as assigned


Requirements

  • Degree in Life Sciences, Engineering, or related discipline
  • At least 5 year of related working experience, preferably in the medical device 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)
  • Knowledge and specialization in Regulatory and Quality Affairs (Quality Control/Assurance) is an advantage
  • Excellent communication skills and English at work proficiency level (writing and conversational)
  • Proficient in Microsoft Office
  • Independent, meticulous, detail-oriented, and proactive
  • Ability to Multi-task & Proactive
  • Positive working attitude with passion to learn and develop
  • Able to adapt in a fast-paced environment


For more information, please apply with a word format CV .


Ambrose Chan

Registration Number: R1218177

EA License Number: 17C8502

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