Medical Device Consultant

  • Galway
  • Eurofins
Job DescriptionJob SummaryThe purpose of this job is to manage and complete consultancy activities in the field of medical devices in Ireland and other European markets as required (limited). This role will include the completion of all activities related to preclinical safety, literature searches and client Regulatory requests/support.Job ResponsibilitiesPerform biological risk assessments, toxicology risk assessments and related activity to validate the preclinical safety of client medical devices.Support client regulatory requests though consulting and complete clinical assessment as required.Stay current and maintain level of expertise in ISO 10993 and regulatory requirements. Take opportunities to upskill and ensure awareness of emerging industry trends and expectations from Competent Authorities (e.g. US FDA).Ensure technical-scientific support to support customer assistance activities and be directly involved in the work on the project under responsibility.Set and maintain project timelines, escalate client concerns.To ensure all related documentation is completed and filed accurately, updated as required and on time in line with company procedures.To cooperate with the European Consultancy GroupTo communicate regularly with their team and all other ancillary groups to ensure information is transferred effectively throughout the organisation. Provide coaching and mentoring to the team as required to improve understanding and compliance in all areas.To continually liaise with management, customers and other members of the organisation on any relevant problem areas or enhancements to the business.To adhere to all company standards in the area of safety, housekeeping and quality, notifying management of any discrepancies.Assessment of test requirements, methods and other client supplied study specifications and information in conjunction with Project Management, Pricing Group, and other Eurofins functions to help design service solutions that meet clients’ requirements. Overall responsibility for the provision of on time, high quality proposals that present the optimum solution for the client whilst ensuring on or above plan profitability.Reporting – provision of account, activity and market status reports as required on a local or global basis as appropriate.Continuous improvement – identification of opportunities for improvement of quality and service with client group, formulation and implementation of action plans for continuous improvementSupport the business in the establishment of a test facility to deliver services as outlined by managementQualificationsEducation / QualificationsBSc or MSc in Biomedical Engineering;Experience of at least 3 years in regulatory and/or testing related to Medical Devices in biocompatibility and/or toxicology.Experience of ISO 10993 series, tools for toxicological assessment and processes relating to biological assessment/evaluation.Experience / SkillsPreferably 3 – 5 years’ experience in a medical device industryExperienced Risk assessor (3 – 5 years).Good commercial awareness and business acumen.Excellent communication skills. Ability to understand customers’ requirements and to be able to devise and articulate the most appropriate solutions.Additional InformationCompany DescriptionEurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 50,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.In 2022, Eurofins generated total revenues of EUR € 6.7 billion, and has been among the best performing stocks in Europe over the past 20 years.