Medical Affairs Specialist

1 week ago


Cork, Cork, Ireland Agilent Full time
Agilent inspires and supports discoveries that advance the quality of life.
We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise.
Agilent enables customers to gain the answers and insights they seek - so they can do what they do best: improve the world around us.
Information about Agilent is available at.Overview:We are looking for a motivated professional to join Agilent's Medical Affairs team, where you will play an important role in driving our work in External Quality Assessment (EQA) and the In Vitro Medical Devices Regulation ( IVDR) EU compliance.
In this position, you will leverage your deep expertise in pathology and diagnostic technologies to drive impactful projects focused on cancer diagnosis.
Your hands-on experience with diagnostic devices and clinical biomarkers in pathology will be essential in shaping strategies that make a real impact on patient care.
You will play a key role in developing and reviewing regulatory documentation, ensuring alignment with clinical and scientific standards.
In addition, work closely with talented colleagues across different teams, gaining exposure to a wide range of initiatives and contributing to Agilent's mission of advancing science and improving health.
This is a great opportunity for someone passionate about applying pathology knowledge to real-world and regulatory challenges and is eager to contribute to meaningful, high-impact work.Key Responsibilities:Monitor and analyze External Quality Assessment (EQA) results – Track Agilent's performance, identify trends, and compare with competitors to support continuous quality improvements.
EQA could be for testing segments in anatomic pathology and/or genomics.Resolve performance issues – Collaborate with cross-functional teams to investigate and fix assay challenges highlighted through EQA results or published scientific research.Ensure compliance with the EU In Vitro Diagnostic Regulation (IVDR) – Support the clinical and regulatory teams in the development and the maintenance of documentation relating to clinical performance.Provide scientific insights – Review and assess scientific literature to generate strong clinical evidence, guide biomarker strategy, and support regulatory documentation.Collaborate across departments – Work closely with Regulatory Affairs, R&D, Quality, and Marketing to align on compliance, communication, and scientific strategies.
QualificationsStrong background in pathology laboratory practices, guidelines and governance.Education– Bachelor's or Master's degree (or equivalent) in Life Sciences, Biomedical Sciences, Pharmacy, or a related field.Experience – At least 4+ years of relevant experience in diagnostics, life sciences, or pharmaceutical industry.EQA expertise – Strong knowledge of External Quality Assessment (EQA) processes and standards, with experience interpreting results and applying them to improve diagnostic product quality.Regulatory knowledge – Solid understanding of the EU In Vitro Diagnostic Regulation (IVDR, EU 2017/746), especially in clinical evidence and performance evaluation.Scientific and analytical skills – Ability to evaluate clinical data, validate biomarkers, and apply evidence-based insights to projects.Collaboration and communication – Proven success working in cross-functional teams and proficiency in written and spoken English.On a personal level, you possess great problem solving / analytical skills, and you are eager to learn about Medical Affairs capabilities such asscientific study design, evidence generation and medical writing.
You have communication/ interpersonal skills to interact at various levels, and you strive to provide excellent customer support.
You enjoy both working within a team and autonomously.We offer:Agilent offers core global benefits to all staff - but in addition to these, the business offers, Stock Purchase Plan, Life Insurance, Pension, Healthcare, Employee Assistance Program, Holiday, and Company activities (these may vary from country to country)An opportunity for you to grow within a world-class company to develop your skills.An independent job among good colleagues, in a growth orientated conglomerate.
You will become part of a caring and fast paced environment, built on integrity, information, and trust.Be part of a company where we value quality in the solutions we deliver to our customers, with our employees and in relation to the processes we work with.A dedication to work/life balance.Additional DetailsThis job has a full time weekly schedule.
It includes the option to work remotely.Our pay ranges are determined by role, level, and location.
Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training.
During the hiring process, a recruiter can share more about the specific pay range for a preferred location.
Pay and benefit information by country are available at: Agilent Technologies Inc. is an equal opportunity employer.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.Travel Required: 35% of the TimeShift: DayDuration: No End DateJob Function: Medical/Clinical

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