Regulatory Affair Associate (Medical Device)

Recruit Express Pte Ltd

Regulatory Affair Associate (Medical Device)

Recruit Express Pte Ltd


Job Nature: Permanent

Position Level: Entry Level, Experienced

Job Category: Product Development/Management, Quality Control/Assurance , Medical/Life Science

Qualification: Bachelor's / Honours, Masters / PhD

Salary: Login to view


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

 


Company Overview

 
Singapore’s Largest & Most Preferred Recruitment Company!
As a premier leading recruitment consultancy in Singapore, our success has been a result of our focus in facilitating the success of our Clients in business whilst enhancing the career opportunities for our Candidates.

With our swift expansion across the region, we now have offices in Singapore, Taiwan, Sydney, Kuala Lumpur and Hongkong as well as a partner network in Shanghai and Japan.

We serve with distinction and provide comprehensive staffing needs. As the total recruitment and staffing solutions partner, our goal is to provide our Clients the best staffing solutions through an integrated database network supported by localized content and services.

EA Licence No.: 99C4599
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