Post Market Surveillance Specialist – Agilent – Glostrup

Job DescriptionOne of our missions at Agilent is to help our customers around the world fight cancer and other life-threatening diseases. By providing our customers with the best solutions to ensure accurate and early diagnosis, we improve patient treatment and enhance survival rates.Organizational StructureAgilent has approximately 17,000 employees spread across Europe, the Americas and Asia Pacific. The global footprint includes sales offices, logistics centers, business facilities, and manufacturing sites in three major geographies. Agilent’s worldwide capabilities enable them to deliver high-quality solutions to their valued customers in 110 countries. Agilent’s footprintThere are 3 Business Units (called Groups in Agilent): Agilent CrossLab Group (ACG)Life Sciences and Applied Markets Group (LSAM)Diagnostics & Genomics Group (DGG) has 6 Divisions:Nucleic Acid Solution Division (NASD)Biomolecular Analysis Division (BAD)Companion Diagnostics Division (CDx)Genomics DivisionManufacturing sites are not always linked directly to each division, as some sites manufacture products that cover 2 or more divisions, e.g. Glostrup site in Denmark is manufacturing primarily for PT but it also manufactures for RP and CDx. Glostrups’ sister-site is based in California, and it manufactures for CDx but also for RP and PT. The whole DGG is dedicated to in-vitro diagnostics (IVD) for oncology.The positionThe position is within DGG, PT/RP/CDx Division. We are expanding our team and are looking for new Post Market Surveillance Specialists. Post Market Surveillance (PMS) department is managing all PMS activities according to the requirements defined in In Vitro Diagnostic medical devices Regulation (IVDR) (EU) 2017/746 as well as regulations under MDSAP. This includes among others preparation and execution of Post-Market Surveillance Plan (PMSP), Post-Market Performance Follow-up Plan (PMPFP), Post Market Surveillance Report (PMSR), Periodic Safety Update Report (PSUR), and Post Market Performance Follow-up Report (PMPFR).The department comprises three (3) specialist, and one (1) student assistant. You will be based in Glostrup, Denmark and will be reporting to the PMS Department Manager.In your role you will:Data managementCollect, refine, categorize and organize data (systematic approach)Troubleshot and present dataPlan together with the other team members timely collection of dataDocumentationWrite relevant reports (PMSR, PSUR, PMPFR)Maintain relevant proceduresFollow current the current regulation and guidelines related to IVD, and update relevant procedures accordingly.Stakeholder managementGather experts’ evaluationsHost and manage meetingsProduct understandingPrepare source codesScreen External Quality Assessments (EQA) dataSearch competitors AEs/FSCAsRead and understand scientific literatureDrive product improvement based on PMS data (PMPF)Identify the needs for updates to the performance evaluationIdentify needs for update of Summary of Safety and Performance (SSP)Identify needs for preventive, corrective or field safety corrective actionsFurthermore, you will support and participate in continuous improvement of the Quality organization, including:Evaluation of internal PMS process and recommend changes to ensure compliance with Agilent Quality Management SystemParticipate in planning, execution and follow up on internal and external auditsSupport relevant Quality projectsYou will have close cross-functional collaboration with among others Quality, Research & Development (R&D), Regulatory Affairs (RA) and Manufacturing.QualificationsMSc. degree within Pharmacy, Medical Engineering, Molecular Biology or other similar natural sciences+3 years of work experience in the medical device or pharmaceutical industryPreferably experience working with In Vitro Diagnostic and/or Medical DevicesStrong knowledge and understanding of standards and regulations: ISO 14971:2019, Regulation (EU) 2017/746, ISO 13485 and regulations covered under MDSAPStrong analytical skills with focus on finding the right solutions in compliance with the regulations.High professional level in written and spoken English and preferably also in Danish Personal skillsData oriented with risk-based approachLEAN mindsetExcellent communicating skillsThrive working cross-functionally with people at all levels of the organizationFlexible, systematic, and engaged team playerRobust with a sense of urgency combined with a good sense of humorSelf-motivated with a high level of engagementAgilent values and cultureYou will become part of a company with culture based on to the values: innovation, trust, respect, collaboration, and uncompromising integrity. Added to these traits are speed, focus and accountability to meet customer needs and build a culture of performance that draws on the full range of people’s skills and aspirations.Agilent Technologies is an equal opportunity employer and value diversity at our company. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, disability status or any other protected categories under all applicable laws.Practical informationDeadline for application: We will be interviewing on-going, and the position will be filled as soon as the right candidate has been identifiedStart: As soon as possibleSalary: According to qualifications and Agilent defined salary rangeAgilent 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 Required10% of the TimeScheduleSchedule:Full timeShiftDayDurationNo End DateJob FunctionQuality/Regulatory

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