Senior Regulatory & Quality Specialist - Medical Devices - Healthcare

PersolKelly

Địa điểm làm việc: Hà Nội

Hết hạn: 27/09/2021

Chi tiết công việc
Giới thiệu công ty

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Location:

Hanoi

All

Work Type:

Permanent

Salary:

Location: Hanoi
Salary: Attractive - Negotiable
Industry: Medical Devices

This vacancy belongs to our client - a multinational company in Singapore that specializes in radiation medical equipment & digital solutions. This person will report directly to Regional RA&QA Manager in Headquarter.

OVERVIEW:

Senior / Specialist, Regulatory Affairs and Quality, Vietnam is responsible for supporting functions related to gaining market access for the regulated products including submissions, communications with regional and business teams, collection of materials, analysing and preparing responses on all governing agency actions.

JOB DESCRIPTION:

Prepare, submit, and manage regulatory applications required for product market approvals in Vietnam
Implement, maintain and support local submission processes and global processes
Coordinate with local consultants and agents who support regulatory submissions
Collate and prepare all materials, reports and follow-ups with regulatory agencies regarding recall activities
Support post-market surveillance activities i.e. complaint Investigations, FSCA, MDR, etc.
Commits to quality - adheres to and improves processes and works
Support in issuing and changing processes and procedures to fit in local statutory and regulatory requirement
Participate in internal and external quality system and design dossier audits
Support re-labelling, second labelling, translation processes when needed
Perform other ad hoc initiatives / activities as per request from function

JOB REQUIRMENTS:

Bachelor's Degree in a technical discipline such as Bio-medical Engineering, Medical Engineering Computer Science, Science or equivalence.
Minimum of 2 years' regulatory affairs, importation experience in medical device industry
Solid working knowledge and experience of Vietnam regulations and standards applicable to medical device market clearance
Excellent verbal and written English and Vietnamese communications skills
Experience in and understanding of medical device regulations of other countries such as Australia TGA, CE MDR/IVDR, Malaysia MDA, Singapore HSA, US FDA, is a plus
Experience in ISO 9001, ISO 13485 audit is a plus
A structured approach to problem solving with an appreciation of quality tools & techniques.
An effective team player who can provide creative solutions - offers proposals and ideas to solve problems.
Confident and open personality who is able to communicate effectively, both written and orally with people at all levels.
A positive attitude towards change to promote the global goals of the business.
Able to work within a multi-cultural environment

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Reference Number:

527641

Contact Details:

Ms. Trang

Profession:

Healthcare > Medical devices

Company:

PERSOLKELLY's Client

Thông tin chung

Ngày hết hạn: 27/09/2021
Thu nhập: Thỏa thuận

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Giới thiệu công ty

Established in 1998, First Alliances is the most well-known as the leading HR consultancy in Viet Nam. We are proud to be the pioneer and constantly...Chi tiết Established in 1998, First Alliances is the most well-known as the leading HR consultancy in Viet Nam. We are proud to be the pioneer and...

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