Job Details: Regulatory Affairs Specialist/FTC


JobsIreland
Jervis Street
Dublin 1
jobsireland.ie
Regulatory Affairs Specialist/FTC
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 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

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