Regulatory Affairs Specialist - IVDR

Job description

JOB DESCRIPTION:Abbott in Ireland Abbott has maintained a strong presence in Ireland since 1946 and celebrates its 80th anniversary in the country in 2026. The company supports the Irish healthcare sector with a broad portfolio spanning diagnostics, diabetes care, medical devices and nutritional products. Today, Abbott employs more than 6,200 people across ten sites located in Dublin, Donegal, Clonmel, Cootehill, Galway, Kilkenny, Longford and Sligo. About Abbott Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries. 1 year contract MAIN RESPONSIBILITIES Supports the preparation of product registration submissions, progress reports, supplements, amendments, and periodic experience reports under guidance. Assists in interactions with regulatory agencies to support timely approval of submissions. Contributes to regulatory activities across the product lifecycle under supervision. Participates in selected regulatory activities such as product plan implementation, regulatory documentation, and compliance support. Supports the timely approval of medical devices and maintenance of regulatory approvals for marketed products. Acts as a supporting regulatory contact for internal stakeholders including marketing and research teams. Provides input to development and/or marketing teams on manufacturing changes, labelling updates, and applicable regulatory requirements with supervision. QUALIFICATIONS AND COMPETENCIESMinimum of a Bachelor’s Degree (BA/BS) from an accredited University Minimum of (1) year of experience in Regulatory Affairs role within a GMP / Biotech / Pharma / Medical Device/ IVD/ Regulated Industry. Strong written and verbal communication skills Ability to adapt quickly and effectively to shifting priorities. Very strong attention to detail Must be able to productively generate quality documentation to meet Program timelines Strong skills in Microsoft Office, especially in Word, Excel, and PowerPoint Good knowledge of Quality/Regulatory requirements in the IVD / Medical Device Industry including Medical Device and IVD Regulations, ISO13485, 21CFR820, ISO14971 and other standards and regulations applicable to IVD / Medical Devices. Adaptability, Innovation, Initiative, Teamwork, Quality of Work, Commitment Connect with us at www.abbott.com or https://www.ie.abbott/, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews. The base pay for this position is N/AIn specific locations, the pay range may vary from the range posted. JOB FAMILY:Regulatory Operations DIVISION:ID Infectious Disease LOCATION:Ireland > Galway : Parkmore East Business Park ADDITIONAL LOCATIONS: WORK SHIFT:Ie - 37.5Hst0 (Ireland) TRAVEL:No MEDICAL SURVEILLANCE:No SIGNIFICANT WORK ACTIVITIES:Not Applicable