Regulatory Affairs Specialist

PE Global; Galway; Hybrid; EUR 40,000 - 55,000; Full time

Job summary

A leading medical device company in Galway is seeking a Regulatory Affairs Specialist for a 12-month contract. In this role, you will coordinate regulatory submissions, prepare necessary documents, and recommend compliance strategies. Ideal candidates should have a University Degree and 1-2 years of relevant experience. The position offers hybrid working options.

Qualifications

• Minimum of 1-2 years of relevant experience in regulatory affairs.
• Competence within job area through advanced education combined with experience.

Responsibilities

• Coordinate and prepare document packages for regulatory submissions.
• Compile materials for submissions, license renewal, and registrations.
• Recommend changes for labeling and clinical protocols.

Skills

Regulatory submissions coordination

Document preparation

Regulatory compliance

Clinical trials strategy

Education

University Degree

Job description

The Role

Regulatory Affairs Specialist for our medical device client based in Galway. This is a 12-month contract role. Hybrid working options.

Job Responsibilities

• 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 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.

Education & Experience

• Requires a University Degree and minimum of 1-2 years of relevant experience.
• Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.

Interested candidates should submit an updated CV.

Please click the link below to apply, or alternatively send an up-to-date CV to [e-mail]

Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland