The Role
PE Global are recruiting for a 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 2 years of relevant experience, or advanced degree with 0 years of 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 aisling.oleary@peglobal.net
****Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland****
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