Experience

National Standards Authority of Ireland

• Ireland
• International Trade and Development
• 100 - 200 Employee

• Quality Officer

  • Jul 2023 - Present



SurgVision GmbH

• Germany
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Quality Assurance Manager

  • Feb 2020 - Apr 2023

• Technical Writer R&D QA Ops

  • Jun 2019 - Feb 2020



Firecrest - ICON's Innovative Site & Patient Platform

• Ireland
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Instructional Designer - ICON (Firecrest Clinical)

  • May 2018 - May 2019

  • Analyze clinical trial protocols and script content to ensure it is technically accurate, clear, concise, and presents a scientific story in a logical, engaging style. • Engage in highly collaborative functions, working closely with Graphic Designers, Clinical Trial Subject Matter Experts Editors, and Project Managers to ensure the technical accuracy of the content. • Review clinical trial protocol updates/amendments to assess their impact on existing training content. • Script high-quality training content, including e-learning programmes and online information tools, in accordance with the clinical trial protocol. • Apply the principles of learning and instruction to ensure that the training content presents the information in an engaging and logical manner, flows well and holds the attention of user from start to finish. • Use defined templates, formats, and styles to ensure that content meets internal, client and industry requirements. Show less



AbbVie

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Site Technical Writer - R&D

  • Dec 2016 - Apr 2018

  Overview: The activities performed in the role of Quality Site Technical Writer include: • Support in assessment, improvement, standardization and creation of standard operating procedures (SOPs), validation documents and regulatory documents for company activity work plans.• Collaborate with SMEs to evaluate, streamline/simplify and standardize all written procedures.• Audit existing SOPs to identify overlap, repeated information or contextual errors.• Create top quality end-user procedural documents that are both technically and scientifically concise and accurate.• Maintain working knowledge of business approach to systems.• Identify gaps and create appropriate documents to address these gaps.• Meet deadlines, work in teams, with effective communication skills to implement improvements.• Adapt and respond to rapid changes in environment and priorities.• Conduct research to obtain information to produce clear concise documents for target audience.• Use specified software packages (FSPro 2013, MS Project, Excel, Word, PPT etc) and standard procedures, responsible for compiling and maintaining all relevant documentation including SOP’s for submission to the Operations, EH&S, Quality Assurance, Site Services, Supply Chain Support and Facilities Leaders. Provide technical and clerical support to the respective teams in the preparation of documentation, collation of data and tracking of SOP’s. • Ensure content complies with regulatory requirements.• Contribute and assists with Corporate, FDA, IMB Auditors and other regulatory bodies during company audits (when applicable). Show less

• Operations Site Technical Writer

  • Jan 2015 - Dec 2016

  Overview: The activities performed in the role of Site Technical Writer include: • Support in assessment, improvement, standardization and creation of standard operating procedures (SOPs), validation documents and regulatory documents for company activity work plans.• Collaborate with SMEs to evaluate, streamline/simplify and standardize all written procedures.• Audit existing SOPs to identify overlap, repeated information or contextual errors.• Create top quality end-user procedural documents that are both technically and scientifically concise and accurate.• Maintain working knowledge of business approach to systems.• Identify gaps and create appropriate documents to address these gaps.• Meet deadlines, work in teams, with effective communication skills to implement improvements.• Adapt and respond to rapid changes in environment and priorities.• Conduct research to obtain information to produce clear concise documents for target audience.• Use specified software packages (FSPro 2013, MS Project, Excel, Word, PPT etc) and standard procedures, responsible for compiling and maintaining all relevant documentation including SOP’s for submission to the Operations, EH&S, Quality Assurance, Site Services, Supply Chain Support and Facilities Leaders. Provide technical and clerical support to the respective teams in the preparation of documentation, collation of data and tracking of SOP’s. • Ensure content complies with regulatory requirements.• Contribute and assists with Corporate, FDA, IMB Auditors and other regulatory bodies during company audits (when applicable). Show less



Institute of Technology, Sligo

• Ireland
• Higher Education
• 300 - 400 Employee

• Further Education - Biopharma and Conflict Managment Courses

  • Apr 2014 - Dec 2014

  Return to further education to upskill into area of biopharmaceutical sciences and Mediation (Conflict Resolution and Management). Return to further education to upskill into area of biopharmaceutical sciences and Mediation (Conflict Resolution and Management).



Abbott

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Regulatory Medical Writer (IVDD Medical)

  • Nov 2008 - Apr 2014

  Experienced in development and maintenance of EU/FDA product files design dossiers Class I (incl., Is, Im), IIa, IIb and III (FDA/EU) electrical/mechanical medical devices/related components and accessories – necessary for timely regulatory approvalsDevelopment and implement global regulatory strategies as per current US FDA regulations (21 CFR 803/-807/-820/-860), European Medical Device and IVD regulations (MDD/MDR/IVDR – e.g., 2007/47/EC and IVDR 2017/746), External ISO Standards (ISO 14971, ISO 9001, and ISO 13485), and other international regulations – Australian Therapeutic Goods Administration (ATGA) Australia, ASEAN, BRIC, LAC countries and Health CanadaExperience with working with US FDA, European Notified Bodies and Competent Authorities and other international regulatory agenciesPrioritization of regulatory workload based on compliance and business objectivesAssisted in international registration requests to support international growthPerformed analysis of complaints to determine if the incident is reportable under EU MDD/MDV requirements and completed MDV/MDR documentation for on-time filingReviewed and processed data, interpreted and summarized laboratory reportsEnsured reliable and accurate maintenance (change control) of Technical DocumentationLiaised with SMEs generate and revise technical documentation to meet regulatory requirementsUpdated and managed Technical Files and International Product Master Files stored on IRIS (International Regulatory Information System)Ensured Abbott Product Lifecycle Management System (APLM) met country and IVDD requirementsUpdated/managed STED/CSDTUpdated and managed Document Management Systems for: (ALMS) (DRS) (ePAS)Supported Abbott EU Medical Writing Group submissionsStrong writing, project management, data analysis, and communication skillsResearched, wrote, edited and proof-read to the highest standard (scientific and grammatical) for first draft abstracts, report and troubleshooting guides Show less

• Manufacturing Quality Auditor - MQA

  • Jun 2007 - Nov 2008

  • Ensured internal auditing was carried out in a timely fashion to meet production schedule at all times (Product Batch Release).• Ensured that manufacturing component inspections were performed in a timely manner and in accordance with procedural requirements.• Provided training assistance to manufacturing operations on defect classification.• Provided reports to MQA team leader highlighting areas of risk that could potentially impact manufacturing operations fill rate (MOFR) – such as expired materials and component re-inspections.• Provided assistance to manufacturing areas on verification of line clearances in the Diagnostic Reagent Operations - Bulk Reagent Operations - BRO fill lines. Show less



Royal College of Surgeons in Ireland (RCSI)

• Ireland
• Higher Education
• 700 & Above Employee

• Research Assistant RCSI Ireland, and University of Sheffield

  • Jun 2006 - May 2007

  Research Project Study: “Bacterial delivery of a novel cytolysin to hypoxic areas of solid tumors” defining a new approach for targeting gene therapy by employing an attenuated strain of the non-pathogenic bacterium, Salmonella typhimurium, in balb/c Murine models. Research Project Study: “Bacterial delivery of a novel cytolysin to hypoxic areas of solid tumors” defining a new approach for targeting gene therapy by employing an attenuated strain of the non-pathogenic bacterium, Salmonella typhimurium, in balb/c Murine models.



Abbott

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Manufacturing Quality Auditor - MQA

  • Feb 2005 - May 2006

  • Ensured internal auditing was carried out in a timely fashion to meet production schedule at all times (Product Batch Release). • Ensured that manufacturing component inspections were performed in a timely manner and in accordance with procedural requirements. • Provided training assistance to manufacturing operations on defect classification. • Provided reports to MQA team leader highlighting areas of risk that could potentially impact manufacturing operations fill rate (MOFR) – such as expired materials and component re-inspections. • Provided assistance to manufacturing areas on verification of line clearances in the Diagnostic Reagent Operations – Diagnostic Reagent Operation - DRO fill lines. Show less



Health Service Executive

• Hospitals and Health Care
• 700 & Above Employee

• Health Care Assistant

  • Jun 1998 - Jun 2004

  Worked in the position of healthcare assistant (HCA) during college. This was a varied role depending on work requirements. Worked as and integral part of a nursing team in both hospital and wider community in residential care homes. Activities including looking after the elderly, disabled or terminally ill patients. Also included working with infants, children, young people and supporting registered nurses in the delivery of nursing care providing duties from helping to feed and wash patients, to assisting with testing urine or blood to perform ECG’s (with training). This role led to new appreciation and understanding of the need to have is compassion for other people, the ability to learn on the job, and to progress in the medical field where I have been able to work towards patient care in my subsequent roles. Show less



Ulster University

• United Kingdom
• Higher Education
• 700 & Above Employee

• Trainee Biomedical Scientist Placement - Blackrock Clinic Job Placement

  • Apr 2004 - May 2004

  Six week job training placement at Blackrock Clinic to understand, learn and develop the following skillsets as part of Post Graduate Certificate in Biomedical Science at University of Ulster Coleraine: Embedding of histopathology solid tumor sections using specialized staining techniques. Developed excellent organizational skills with good attention to detail. Adhered to Standard Operating Procedures and Health and Safety requirements. Six week job training placement at Blackrock Clinic to understand, learn and develop the following skillsets as part of Post Graduate Certificate in Biomedical Science at University of Ulster Coleraine: Embedding of histopathology solid tumor sections using specialized staining techniques. Developed excellent organizational skills with good attention to detail. Adhered to Standard Operating Procedures and Health and Safety requirements.



Bio-Medical Research Ltd

• Ireland
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Line Operator - Slendertone

  • Jun 1994 - Dec 1994

  Gap period to consider future direction for employment so I took a paid internship where I assembled, tested and packaged the SLENDERTONE GymBody 8 Electronic muscle toner (Type 310) for 6 months. After which, I returned to education to further my studies. Product Description: Slendertone GymBody 8 · battery operated Muscle Stimulator ·which utilized 8 adhesive pads, 4 leads, slendertone main control unit which attached to the following regions of the body: stomach, bottom and back chest, arms and legs. Show less