Regulatory Affairs Specialist

About Abbott

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 114,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

Abbott in Ireland

Abbott 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 Galway

Abbott 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.

The Regulatory Affairs Specialist provides a support role to the IDEM Business Unit, their Manufacturing Site and key project activities. The Regulatory Affairs Specialist reports to the Manager of Regulatory Affairs.  The role is based in Galway, Ireland. This position applies advanced regulatory expertise in the Medical Device / IVD area to guide cross-functional partners and demonstrates strategic thinking and creativity in support of key business programs as a legal manufacturing site. This site will act as the legal manufacturing site and Authorized Representative site for the IDEM non-EU based physical manufacturing sites.

• As part of the IDEM Business Unit Regulatory Affairs team, provides regulatory support for new products and changes to existing products to ensure efficient and compliant business processes and environment.   

• Assists in preparation of regulatory documents including Technical Documentation and Design Dossiers for CE marked and WHO prequalified products

• With guidance from RA Manager, updates and maintains Technical Documentation and Design Dossiers for CE marked and WHO prequalified products

• Prepares and submits product registration files to International RA teams in order to obtain and maintain marketing authorisations worldwide

• Works closely with relevant manufacturing sites and other functions to obtain  all the necessary documents to support product registration, renewal or amendment to existing product certificates in a timely manner.

• Provides post market maintenance support to commercial products as necessary to ensure ongoing regulatory approval. This includes supporting global certification activities and regulatory compliance activities, including manufacturing site registration, external regulatory agency audits and internal audits as needed.

• Coordinates change reviews with international RA teams to determine global change impact and consequent submission requirements by sending out change notification to the teams, compiling responses and documenting them within the appropriate QMS system

• Reviews complaints, provides regulatory assessments and completes associated reporting to relevant agencies as per the applicable regulatory reporting requirements globally

• Identifies and develops best practices within the Regulatory Affairs department including continuous development initiatives

• Ensures personal understanding of all quality policy/system items that are personally applicable and carries out duties in compliance with established business policies.

• Follows all work/quality procedures to ensure quality system compliance and high-quality work.

• Collaborate with cross-functional global teams functional teams including but not limited to: IVDR teams, EU Regulatory, International Regulatory, Marketing / PLC, Supply Planning, Customer Service, etc. to ensure all internal and external requirements are met, prior to product release

• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements

• Develop and maintain strong and effective relations with internal/external personnel

• Other duties as assigned, according to the changing needs of the business

• Minimum of a Bachelor’s Degree (BA/BS) from an accredited University

• Minimum of  (2) years of experience in Regulatory Affairs role within a GMP / Biotech / Pharma / Medical Device/ IVD/ Regulated Industry.

• Regulatory experience is desirable, however, candidates with a relevant experience will also be considered.

• Strong written and verbal communication skills

• Demonstrated success in the GMP / Biotech / Pharma / Regulated Industry.

• 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

• Flexible scheduling (if needed and advance notice is given)

• Strong skills in Microsoft Office, especially in Word, Excel, and PowerPoint

• Excellent 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

In specific locations, the pay range may vary from the range posted.