Product Stewardship Specialist – IVDR

Job title: Product Stewardship Specialist – IVDR

Company: Abbott


Job description: JOB DESCRIPTION:About AbbottAbbott 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 114,000 colleagues serve people in more than 160 countries.Abbott in IrelandAbbott has been operating in Ireland since 1946 and serves the Irish market with a diverse range of healthcare products including diagnostics, diabetes care, medical devices and nutritional products. In Ireland, Abbott currently employs about 6,000 people across ten sites located in Dublin, Donegal, Clonmel, Cootehill, Galway, Kilkenny, Longford and Sligo.Abbott GalwayAbbott in Galway serves as the international hub for Abbott’s Rapid Diagnostics business, which delivers annually more than 2 billion tests. As the global leader in point-of-care diagnostics, Abbott offers the broadest portfolio of best-in-class rapid tests, services, and handheld devices across all healthcare settings: the lab, the clinic, remote healthcare outposts, retail outlets, the patient’s bedside and at home. Our industry-leading near patient tests and services are unmatched across key health and therapeutic areas, including: infectious disease, cardiometabolic & informatics, toxicology and consumer diagnostics.One of the key functions in Galway is Global Business Services, which provides number of shared services activities across finance, purchasing, quality, technical and customer services for Europe, Middle East and Africa (EMEA). Various global and EMEA commercial and operational management teams across our infectious disease and cardiometabolic businesses are also based in Galway, overseeing the supply of millions of rapid tests from HIV to diabetes to COVID-19, to patients in many regions across the world.Purpose of the JobThe Product Stewardship specialist is responsible for executing elements of the Divisional Product Stewardship strategy across the Infectious Disease business to ensure compliance with Product Stewardship regulations, internal policies, and procedures. This role will provide technical expertise to the cross functional partners within the businesses as part of the Product Stewardship Team.Major Responsibilities

• Carries out duties in compliance with established business policies and procedures
• Assess products for compliance with applicable Product Stewardship legislation, including EU REACH and RoHs and similar global regulations, EU CLP, EU MDR/IVDR, EU BPR, EU POPs, CA Prop 65, US Conflict Minerals, and EPR (WEEE, Battery, Packaging).
• Provides expert regulatory support and interpretations within a Cross Functional Project team
• Assesses the impact of new and emerging regulations on products and processes and guides the implementation of appropriate compliance measures,
• Develop a working knowledge of business information systems (e.g. SAP, Agile, eVitality, Ensur) to support management of product data in CMap
• Support Extended Producer Responsibility data gathering and processing at a business unit level level to support annual filing
• Regularly communicates a high-level summary on status of the areas of responsibility to management.

Education & Competencies

• A Bachelor’s or higher in Toxicology, Chemistry, Engineering, or other science.
• Minimum of 5 years’ experience in Product Stewardship or a related field such as R&D, operations, technical support, quality or regulatory within the Pharma or Medical Device industries.
• High Proficiency in MS Office software.
• In order to interact with sites on different time zones occasional out of hours working required.
• Working knowledge of relevant regulations including REACH and/or other global REACH like Regulations, RoHS, CLP, Conflict Minerals and Extended Producer Responsibility requirements.
• Ability to coordinate meetings (by phone, video conference and face to face) to drive results and build relationships.
• Demonstrated administrative, written and verbal communication, negotiation and influencing skills.
• A track record of supporting multifunctional teams.
• Organised, detail oriented, have a high level of confidentiality, and ability to work under pressure with changing priorities and deadlines.
• Ability to be resourceful and proactive when issues arise.
• Excellent organizational skills.
• Multitasking and time-management skills, with the ability to prioritize task

Connect with us at and on , , , and .The base pay for this position is N/AIn specific locations, the pay range may vary from the range posted.JOB FAMILY: EngineeringDIVISION: ID Infectious DiseaseLOCATION: Ireland
Galway : Parkmore East Business ParkADDITIONAL LOCATIONS:WORK SHIFT: Ie – Shftpre0 (Ireland)TRAVEL: Not specifiedMEDICAL SURVEILLANCE: NoSIGNIFICANT WORK ACTIVITIES: Not Applicable

Expected salary:

Location: Galway

Job date: Sun, 06 Apr 2025 07:55:49 GMT

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