Regulatory Affairs Specialist

A Regulatory Affairs Specialist is required by CareerWise Recruitment for our multinational medical device client in Galway for a fulltime, hybrid role on an initial 12-month contract.

The Regulatory Affairs Specialist will direct or perform coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.

THE ROLE:

• Leads or compiles all materials required in submissions, license renewal and annual registrations.
• Recommends changes for labelling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• Monitors and improves tracking / control systems.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.
• Recommends strategies for earliest possible approvals of clinical trials applications.

REQUIREMENTS:

• Bachelor’s Degree (Level 8) in a relevant Science, or other technical discipline.
• 2+ years’ experience in regulatory affairs.
• Experience in preparation of document packages for regulatory submissions.
• Experience in regulatory review of change control.
• Experience with Software in a medical device or software as a medical device and/or pharmaceutical experience would be of interest.

Please call Laura Gallagher today for further information on 087- 4526468 or email: lgallagher@careerwise.ie

CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

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