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Abbott is seeking a Regulatory Affairs Specialist for its Galway location, focusing on providing regulatory support for medical device and IVD products. The role requires experience in regulatory affairs within a regulated industry and offers a fully remote work environment.
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Job Summary
The role provides advanced regulatory expertise to guide cross-functional partners as a legal manufacturing site for the IDEM Business Unit.
Responsibilities include preparing technical documentation and design dossiers for CE marked and WHO prequalified products while ensuring global compliance.
The position requires coordinating change reviews with international teams and supporting post-market maintenance activities including audits.
Matching Summary
Match Score: 75
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Abbott is seeking a Regulatory Affairs Specialist for its Galway location, focusing on providing regulatory support for medical device and IVD products. The role requires experience in regulatory affairs within a regulated industry and offers a fully remote work environment.
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Skills & Requirements
Must-have
Bachelor's Degree from accredited University
2 years Regulatory Affairs experience
GMP Biotech Pharma Medical Device IVD industry
Knowledge of ISO13485 and 21CFR820 regulations
Experience with CE marking and WHO prequalification
Nice-to-have
Strong written and verbal communication skills
Ability to adapt quickly to shifting priorities
Excellent Microsoft Office skills especially Excel
Innovation and initiative in regulatory processes
Teamwork and commitment to quality work
Key Requirements
Minimum Bachelor's Degree required
Minimum 2 years RA experience in regulated industry
Expert knowledge of IVD/Medical Device regulations