Regulatory Affair Associate (Medical Device)

Recruit Express Pte Ltd| Date Posted: 29-Jul-2019
EA Licence No: 99C4599|EA Personal Registration No: R1763413
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Job Nature:
Permanent
Position Level:
Entry Level, Experienced
Qualification:
Diploma, Bachelor's / Honours, Masters / PhD

Job Description

Job Responsibilities:

 

  • Participate in the development and lifecycle management of products to ensure compliance with all internal and external requirements for markets such as EU, US, Japan, Korea and APAC.
  • Develop, implement and maintain regulatory strategies and regulatory submission plans in order to meet project milestones.
  • Prepare, update and maintain technical files/submission dossiers as per applicable SOPs, and liaise with the relevant departments as required.
  • Work with project teams to resolve complex project issues by strategically interpreting and clearly communicating regulatory requirements.
  • Review and approve documents such as Engineering Change Orders, Design Change Notices and validation reports for scientific merit and regulatory appropriateness for compliance with international regulations and standards.
  • Ensure labelling meets all relevant international requirements.
  • Conduct regulatory assessments for change controls in line with international regulatory requirements.
  • Support internal and external audits as required.
  • Contribute to the review and improvement of regulatory processes.

Job Requirements:

  • Min. degree or equivalent in sciences, medicine, pharmacy, engineering or another relevant discipline in the area of regulatory affairs or medical devices.
  • Min. 3-5 years of experience in regulatory affairs and/or in quality management systems relating to medical devices, preferably with higher classes (e.g. III in EU) in a global or regional capacity.
  • Knowledge of international regulations and standards for medical devices.
  • Experience in ISO certification and audits will be advantageous.
  • Experience with the manufacturing of high-tech medical products is preferred.
  • Working knowledge and experience with competent authorities are an advantage.

Interested Candidates please forward your updated CVs to:

Alex Goh Hock Leong – R1763413 at [Click Here to Email Your Resume]
Recruit Express Pte Ltd, EA License No.: 99C4599

All candidates’ informations will be treated with the strictest confidence

 

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