Our client, an Irish global healthcare company, is renowned for developing advanced technology solutions to tackle the most challenging healthcare problems. As a leader in healthcare technology, they have consistently brought innovative products to market. Due to expansion within their quality division, they are seeking a Principal Regulatory Affairs Specialist to join their dynamic team.

The Position

• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
• Leads or compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, 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.
• Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
• May act as a mentor to colleagues or may direct the work of other lower level professionals.
• The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialised knowledge and skills normally acquired through advanced education (typically University).

The Person

• Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience.
• May have broad knowledge of project management.
• Requires a University Degree and minimum 10 years of relevant experience, or advanced degree with a minimum of 7 years of relevant experience.

To discover more about this opportunity, apply now or contact Lewis Murray in HRM Search Partners on +353 872043307 for a confidential discussion.