Principal Regulatory Affairs Specialist - County Galway, Ireland - Cpl

Description

My client, a leading medical device manufacturer, are seeking a Principal Regulatory Affairs Specialist for their Galway site. Regulatory Affairs is a key function within the business and this role is supporting the Structural Heart business.

Responsibilities

· Develop robust regulatory strategies

· Engage with regulatory agencies as the lead representative of the company

· Resolve questions from regulatory agencies for changes to existing products

· Lead regulatory filings to support submissions, license renewal and annual registrations.

· Support manufacturing strategy via a robust change control approach

· Mentor and coach more junior members of the department

· Keep abreast of regulatory procedures and changes.

· Develops internal procedures to ensure continuous regulatory compliance

· Influences clinical evidence strategy to support labelling content, marketing claims and regulatory compliance.

· Supports regulatory compliance activities, including manufacturing site registration & GMP audits as needed.

Requirements

· Level 8 Science or Engineering Degree; Masters desirable

· Regulatory experience in Medical Devices and / or Pharmaceuticals is required.

· A Regulatory Affairs qualification is desirable.

If interested please send your CV to

#LI-EL2

#CplEmerLong