Job vacancy Senior Office Staff (ra&qa)


Announced
10 June, 2023
Job Type
Employee
Job Status
Full Time
Job Title

Senior Office Staff (ra&qa)

Job Location
Job Presentation
SENIOR OFFICE STAFF (RA&QA)
COMPANY OVERVIEW
One of the leading medical technology companies from Japan in the world with a commitment to “Contributing to society through healthcare” need to employ a Senior Office Staff.
JOB RESPONSIBILITIES
  • Responsible for implementing and managing the regulatory activities of medical devices in accordance with MOH registration guidelines including new product submission, renewal submission, classification certificate, variations submission.
  • Liaise with MOH to ensure products are approved for sales as soon as possible.
  • Responsible for sub-labeling, advertising, and promotion activities for regulatory compliance
  • Responsible for post market surveillance activities i.e., Complaint report, FSCA, recall, etc.…
  • Ensure product compliance for tender business.
  • Responsible for database, processes, and systems to manage and maintain all regulatory documents needed for regulatory, tender application and sales.
  • Provide regulatory support in tender submission and corresponding inquiry as required.
  • Input and update global database and system as required.
  • Deliver the training of processes, procedures, work standards/instruction to internal and external stakeholders and ensure the compliance within delegated function.
  • Participate in prediction of effect of changes of regulations, policies, or procedure.
  • Coordinate with other departments i.e., supply chain, business unit to support for product’s availability on the market.
  • Responsible for internal and external audits such as audit from suppliers or audit to distributors.
  • Assists in any ad hoc tasks as required.
  • Assess regulatory needs for pre- and post-marketing submission.


JOB REQUIREMENTS
 
  • A Native Vietnamese speaker with fluency in English, and super communication skills both in writing and speaking.
  • Commercially astute, eager to partner with business, with strong influencing and interpersonal skills.
  • Must be able to communicate orally and in written form in concise and articulate manner.
  • Strong analytical and problem-solving skills
  • A Bachelor of Science Degree with at least 3-5 years’ experience in Quality Assurance and Regulatory Affairs in MNC for Medical Devices or Pharma industry.
  • Good working knowledge of the following software programs: Microsoft Word, Excel, PowerPoint, and Outlook.
  • Proofed experience performing internal/external audits.
  • Writing standard operating procedures and work instructions.
  • Experience managing documentation in English and fluent speaking the language is desired.

JOB BENEFITS
 
  • Salary from 1200 $ ~ 1500$ VND Monthly + Bonus (Negotiable)
  • 13th month salary + allowance
  • Premium Healthcare & Insurance Package.
  • Global working environment & Abroad Opportunities
  • Training & Development Opportunities

Apply online or feel free to contact us directly for more information about this opportunity. Due to the high volume of applicants, we regret to inform that only shortlisted candidates will be notified. Thank you for your understanding.

#LI-JACVN
#Hanoi 
Valid Till
8 Jun, 2024 (70 days left)

JOB BY
JAC Recruitment Vietnam
19th Floor, Ruby Tower 81-83-83B-85 Ham Nghi District 1, Ho Chi Minh City
  +84 28 3821 7730

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How to Apply?

Please apply for this job on JAC-Recruitment.vn website:

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