JOB OVERVIEW
The Regulatory Affairs Specialist will support the product
development, Regulatory complaint management and regulatory approval
on sustaining projects.
ROLE AND RESPONSIBILITIES:
? Support the creation & maintenance of product design and technical
documentation in compliance with the relevant regulations and
standards.
? Support the development and submission of high quality regulatory
files to the relevant ethical committees and regulatory agencies,
ensuring successful approval.
? Organise and maintain regulatory submissions with regulatory
authorities.
? Co-ordinate and, where appropriate, conduct gap assessment
activities in line with updated regulatory requirements and standards.
? Keep up to date with changes in applicable regulatory requirements
and standards.
? Assist company preparation for inspection by a notified body and
regulatory authorities.
? Co-ordinate and progress Adverse Event reporting to regulatory
authorities.
? Ensuring adherence to all organisational and external regulatory
requirements.
WHAT YOUR BACKGROUND SHOULD LOOK LIKE:
REQUIREMENTS:
? Bachelor**Apply on the website**;s or master**Apply on the
website**;s degree in science or related disciplines.
? Minimum of two (2) years of related experience in Regulatory
Affairs, Quality or Design Assurance an advantage.
? Experience of preparing technical documentation for
submission to regulatory agencies.
? Class III medical device experience is preferred.
? Working knowledge of GMP, FDA QSR and ISO **Apply on the website**
requirements.
? Excellent communication, organisational and time management skills
COMPETENCIES Values: Integrity, Accountability,Teamwork, Innovation Position: Regulatory Affairs Specialist ( month FTC)
JOB OVERVIEW
The Regulatory Affairs Specialist will support the product
development, Regulatory complaint management and regulatory approval
on sustaining projects.
ROLE AND RESPONSIBILITIES:
? Support the creation & maintenance of product design and technical
documentation in compliance with the relevant regulations and
standards.
? Support the development and submission of high quality regulatory
files to the relevant ethical committees and regulatory agencies,
ensuring successful approval.
? Organise and maintain regulatory submissions with regulatory
authorities.
? Co-ordinate and, where appropriate, conduct gap assessment
activities in line with updated regulatory requirements and standards.
? Keep up to date with changes in applicable regulatory requirements
and standards.
? Assist company preparation for inspection by a notified body and
regulatory authorities.
? Co-ordinate and progress Adverse Event reporting to regulatory
authorities.
? Ensuring adherence to all organisational and external regulatory
requirements.
WHAT YOUR BACKGROUND SHOULD LOOK LIKE:
REQUIREMENTS:
? Bachelor**Apply on the website**;s or master**Apply on the
website**;s degree in science or related disciplines.
? Minimum of two (2) years of related experience in Regulatory
Affairs, Quality or Design Assurance an advantage.
? Experience of preparing technical documentation for
submission to regulatory agencies.
? Class III medical device experience is preferred.
? Working knowledge of GMP, FDA QSR and ISO **Apply on the website**
requirements.
? Excellent communication, organisational and time management skills
COMPETENCIES Values: Integrity, Accountability,Teamwork, Innovation
We need : English (Good)
Type: Permanent
Payment:
Category: Others