Regulatory Affairs Manager

Role:

Regulatory Affairs Manager

This is an excellent opportunity for either an existing RA Manager, seeking a change or someone with 7+ years RA experience and seeking to move into a managerial position. Contract is due to start in early 2011 and those interested in the position should express their interest ASAP as interviews will be held prior to Christmas shutdown.

This position may also suit someone wishing to work on a part time basis (i.e. a 4 day working week). It is an office based position so you must be willing and prepared to work in Dublin West.

For information, please contact Jenny Navan in Cpl on 00 353 1 614 6072 or email Jenny.Navan@cpl.ie

Duties and Responsibilities:
Submission of marketing authorisation applications and variations

Liaison with Health Authorities regarding regulatory issues

Maintenance of the regulatory system for regulatory devices

Maintenance of regulatory dossiers

Maintenance of the company manufacturing license

Reporting of medical vigilance and pharmacovigilance issues to the regulatory authorities

Implementation of design control, approval of risk analyses and maintenance of the design dossier

Approval of procedures, specifications, validation protocols and reports and batch records

Regulatory review and approval of all changes concerning the companies manufactured products

Review of Quality Management System related documentation for compliance with the regulatory file

Provision of support to the corporate regulatory affairs department

Participate in Regulatory audits from IMB, TUV, etc



Skills/Knowledge/Experience:

A minimum of 5 years experience in Regulatory Affairs

An appropriate life sciences degree

Excellent written and verbal communication skills

Experience in ISO 13485:2003

Knowledge of GMP, GCP and GLP regulations

Ability to work independently

Keywords:

Regulatory Affairs |   Reg Affairs |   Regulatory Manager |   Reg Manager |   Pharma |   Pharmaceutical |   IMB |   FDA |   Dublin |   Science |   Med Dev |   Medical Device |