Senior Regulatory Affairs Specialist

Westmeath  ‐ Onsite
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Keywords

Description

Are you a hardworking and proactive Regulatory Affairs Specialist looking to take the next step up to a Senior Regulatory Affairs Specialist role?

As the Senior Regulatory Affairs Specialist you will be responsible for determining and supporting the regulatory activities which lead to, and maintain regulatory compliance and approval the companies products globally

Key responsibilities -Coordination and management of regulatory and product registration activities -Preparation of internal reports and change control documents, and the review of documents for potential impact on global regulatory submissions.
- Approval of labelling materials in compliance with international regulations/standards, and ensure product claims are consistent with product approvals.
-Preparation of product registration files for submission to global regulatory bodies/agencies, to support EU CE Marking, FDA, Canadian and foreign regulatory submissions, in order to obtain product approvals and maintain regulatory compliance with international regulatory requirements. -Generate supporting design documentation risk analyses and essential requirements checklists by working with cross functional teams and across sites to support technical files completion.
-Preparation of information to support Product Tender Applications in the international markets
-Preparation of regulatory documentation to support customer services with the shipment of products
-Support Notified Body, FDA and international regulatory agency audits
-Support maintenance of product registration database
-Review and evaluate technical and scientific data and reports and incorporate them into documents for submission to the EU, FDA and foreign regulatory agencies

Qualifications: - Degree level life sciences, engineering or scientific qualification,
- 2 -3 years minimum regulatory experience in the medical industry a prerequisite.
- Knowledge of FDA's 21 CFR Part 820 (Quality System Regulation), ISO 13485:2003, Council Directive 93/42/EEC June, 1993 (Medical Device Directive), and the Canadian Medical Device Regulations, 2006 at an advanced level.
- Experience in preparation for notified body inspections

This in an immediate requirement, interviews will take place immediately.
If you are interested in this exciting opportunity and have the relevant skill s and experience contact me Anna Mooney .

To find out more about Real please visit www.realstaffing.com
Start date
12/2013
From
Real Staffing
Published at
14.11.2013
Project ID:
626806
Contract type
Permanent
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