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Regulatory Affairs Specialist - PMS - IVDR, Galway
Client: Abbott
Location: Galway, Ireland
Job Category: Other
EU work permit required: Yes
Job Reference: 8231eada922e
Job Views: 5
Posted: 16.06.2025
Expiry Date: 31.07.2025
Job Description:
FTC 12 months
Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, supporting diagnostic testing for disease management. IDEM is a significant business unit supporting growth in COVID-19 related products in over 70 countries.
Purpose of the Job:
The Regulatory Affairs Specialist supports the administration and development of the EU Authorised Representative (AR) and UK Responsible Person (RP) activities according to procedures and processes.
You will support the nominated Person Responsible for Regulatory Compliance (PRRC) to ensure oversight of activities is maintained and updates are actioned through the RDIL Quality Management System. You will also support the UK Responsible Person(s) in similar oversight roles.
Major Responsibilities:
* Ensure duties comply with established policies and procedures.
* Support development and implementation of Quality Processes per ISO, FDA, MHRA, HPRA, and other agencies.
* Assess regulatory status of products regarding EU MDR / IVDR and UK/Switzerland MD and IVD regulations.
* Assist with internal and external quality audits.
* Update databases with license, registration, renewal, and product information, including EUDAMED.
* Maintain professional behavior reflecting positively on the company.
* Understand and be aware of quality implications of job performance.
* Perform additional duties and projects as assigned.
* Act as contact point for customer sites and regulators regarding AR and UK RP requests.
* Manage documentation for product registration or removal.
* Review and update external databases for product and manufacturer information.
* Handle requests for regulatory documents such as Certificates of Free Sale.
* Review and administer regulatory, AR, and UK RP documents.
* Report complaints or potential complaints to PRRC, customer sites, and Abbott systems.
* Follow Abbott policies, procedures, and methodologies.
* Process purchase requisitions and invoices.
* Perform other duties as assigned by PRRC or line manager.
Education & Competencies:
* Fluent in business English, with strong interpersonal and communication skills.
* Experience with AR activities and medical device or IVD regulation is desirable but not essential.
* Bachelor’s Degree in a related field is desirable but not essential.
* Proficient in MS Office.
* Flexible to travel and work out of hours as needed.
* Excellent organizational, administrative, and support skills.
* Ability to coordinate meetings and support multifunctional teams.
* Strong communication, negotiation, and influencing skills.
* Organized, detail-oriented, and able to work under pressure and changing priorities.
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