Global Regulatory Affairs Specialist – Medical Devices

Cook Medical Incorporated; Limerick; On-site; EUR 60,000 - 85,000; Full time

Job summary

Cook Medical Incorporated is seeking a Regulatory Affairs Specialist 2 in Ireland to help develop regulatory strategies for medical devices and coordinate submissions across target markets.

You will act as a liaison between Cook's manufacturing, local affiliates, distribution partners and regulatory authorities, ensuring timely registrations, compliance with ISO, EU and FDA standards, and ongoing post-market regulatory support across multiple projects.

Qualifications

• Third level qualification in Science/Engineering; 3–5 years in a regulated industry desirable.
• Knowledge of ISO, EU and FDA medical device standards required.
• Knowledge of medical device quality standards or similar regulated industry.

Responsibilities

• Understands products and regions assigned; communicates regulatory requirements to RA team.
• Develops global regulatory strategies for medical devices with other teams.
• Prepares regulatory submissions for target markets for new products or changes.
• Maintains registration information and ensures timely re-registrations.
• Coordinates with regulatory authorities, affiliates, partners to achieve approvals.
• Provides regulatory support to Cook functional units and handles change requests.

Skills

Regulatory affairs

Communication skills

Problem solving

Microsoft Office

Education

Science/Engineering degree

Job description

Cook Medical Incorporated is seeking a Regulatory Affairs Specialist 2 in Ireland to help develop regulatory strategies for medical devices and coordinate submissions across target markets.

You will act as a liaison between Cook's manufacturing, local affiliates, distribution partners and regulatory authorities, ensuring timely registrations, compliance with ISO, EU and FDA standards, and ongoing post-market regulatory support across multiple projects.