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Job ref no.: CT3114389-01#7936

Regulatory Affairs Engineer

Vincent Medical Holdings Limited

Benefits
  • 5-day week
  • Discretionary bonus
  • Medical plan

To cope with the growth of the business of the HK listed company, we cordially invite high caliber with energetic talents to join us on this position :

Responsibilities:

  1. Works closely with Global Regulatory Affairs to identify applicable regulatory requirements, and to translate the requirements into work tasks for Engineering development and maintenance plans.
  2. Understands new and changing regulations identified by Global Regulatory Affairs. Determines the impact on new product development/maintenance activities and effectively communicates the outcome to Engineering.
  3. Serves as a resource to the engineering teams during product development to ensure the necessary steps are taken during a project for successful product registrations.
  4. Work with Engineering to develop productive verification and validation strategies needed for a successful Regulatory registration.
  5. Participates in the planning and executing product safety and performance standards (e.g. UL, CSA, IEC and ANSI/AAMI.) with third-party laboratories.
  6. Collaborates with Global Regulatory Affairs to understand “current thinking" of regulatory agencies and to assist Engineering in applying US FDA, etc. guidance documents to their designs.
  7. Comprehends new technologies or design concepts and works with Global Regulatory Affairs to identify applicable regulations and standards.
  8. Accurately populates and maintains the global registration database, to ensure maintenance activities are planned for by Engineering to sustain compliance through a product’s lifecycle.
  9. Evaluates product design changes and, working with Global Regulatory Affairs, determines impact on existing product registrations and licenses.
  10. Supports Global Regulatory Affairs personnel during product registrations.
  11. Assists Quality Assurance and Regulatory Affairs during audits conducted by regulatory agencies.
  12. Assists Sales and Marketing in responding to technical questions arising from tenders or other sales efforts.
  13. Performs other duties as requested.

 

Requirements

  1. BS in Engineering or equivalent four-year degree.
  2. At least 3 years relevant work experience in the medical device field.
  3. Strong working knowledge of standards relevant to medical device safety and performance; experienced with IEC 60601 standards.
  4. Strong technical acumen, including ability to read and understand product, hardware and software requirement documents, design description documents, etc.
  5. Previous US 510(K), Health Canada and CFDA submission experience is preferred.
  6. Excellent interpersonal and verbal/written communication skills. Fluent in English.
  7. Strong analytical skills.
  8. Ability to work well both individually and in groups.
  9. Calm under pressure. Good listening skills.
  10. Proactive, flexible and adaptable. Able to learn new skills and concepts quickly.
  11. Good organizational and planning skills. Detail orientated.
  12. Ability to manage time and prioritize work.
  13. Must possess strong decision making and problem solving skills.
  14. Must be able to work with minimal direction, be highly motivated, and be a team player.
  15. Advanced Microsoft Office skills including : Word, Outlook, Excel and PowePoint.
  16. Comfortable working with ambiguity and change. Must be able to work in a fast pace environment.
  17. Must be a team-player, possess outstanding customer service skills and be self motivated.
  18. Acts with a sense of urgency, illustrates ambition, and drives for completion of task and projects.
  19. Must have the ability to initiate and develop creative solutions.
  20. Possess the ability to manage time and prioritize critical priorities.
  21. Must demonstrate the ability to increase knowledge.

 

This position acts as a liaison between Global Regulatory Affairs and Engineering, providing technical interpretation of domestic and international regulatory requirements for new product launches and changes throughout the product lifecycle. Responsible for identifying and planning ongoing maintenance tasks required to maintain product licenses and registrations.

 

Attractive remuneration package is provided to the right candidate, including 5 day work, incentive bonus & medical insurance. Interested parties please send your full resume with CURRENT and EXPECTED salary by clicking Apply Now.

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More job information
Job ref no. CT3114389-01#7936
Salary
  • N/A
Job Function
Industry
Employment Term
  • Permanent
  • Full-time
Experience
  • 3 years
Career Level
  • Middle management level
Education
  • Diploma or equivalent