Clinical and Post Market Surveillance Specialist
Ferrosan Medical Devices A/S is looking for a highly professional, committed and motivated Clinical and Post Marketing Surveillance Specialist who can help ensure our continued international success and position in current markets.
As a Clinical and Post Market Surveillance Specialist, you will work closely with R&D, Commercial Development, New Business Development and international partners, to ensure delivery of clinical evaluations and post market surveillance activities to support class III medical devices and combination products within the field of surgical hemostasis. The purpose of the post market surveillance activities is to generate information regarding the usage and the clinical performance of Ferrosan Medical Devices products and accurately characterize the real-world device evidence as part of a continuous product lifecycle management.
Among many versatile tasks you are responsible for:
• Develop Post Market Surveillance Plans for the collection of post-launch data on device performance and safety as required by the Medical Device Regulation (MDR) and US FDA.
• Ensure integration of post-market surveillance data into clinical evaluation reports (CER) and risk analyses.
• Prepare credible and robust systematic literature reviews on the clinical performance and safety of medical devices designed for hemostatic management during surgery.
• Collaborate with stakeholders to assure that the level of clinical documentation is adequate and proportional with the risk classification of the device.
• In collaboration with other departments, assist, when applicable, in proactive post market surveillance activities including end-user surveys among nurses/medical doctors and expert focus groups.
• Write and update Periodic Safety Update Reports (PSUR), and Summary of Safety and Clinical Performance (SSCP).
• Responsible for vigilance activities, analysis of incidents and mitigation to ensure the device and patient safety are maintained.
• Monitor and handle adverse events including evaluation and submission of Medical Device Reports according to regulatory timelines. Support statistical analysis of adverse events trends.
• Prepare and maintain clinical evaluation and post market surveillance standard operating procedures, ensuring compliance with relevant global regulations and guidelines.
• Ensure effective processes for the company’s post-market surveillance activities and adverse event reporting.
• The successful candidate will have an academic background (Master degree or PhD) within life sciences (human biology, pharmacy, chemistry or similar).
• Preferably, you have at least 2 years of experience with clinical /scientific affairs, post market surveillance and/or vigilance from the medical device / life science industry.
• Experience with conducting high quality systematic literature reviews applying methodological rigor and robust scientific judgment is essential.
• Excellent scientific writing skills, distilling complex scientific and clinical information into clear and credible clinical evaluation reports (CER) and related documents
• Strong analytical skills, attention to details and ability to clearly understand and communicate information related to clinical evaluations, post-market surveillance activities and related processes and tasks.
• Experience with ISO 13485, MEDDEV 2.7/1, FDA 21 CFR part 800-898 and MDD/MDR is an advantage.
• As a person, you are curios, self-driven with a “can-do” attitude who thrives in a dynamic environment.
• Proficiency in English and Danish
Working at Ferrosan Medical Devices
Ferrosan Medical Devices A/S is driven by a dedicated energetic organization with impressive growth. Our company has 200 employees covering all aspect of tasks related to product development and production of medical devices and combination products. The position is new and will have reference to the Regulatory Affairs Manager.
Please submit your application including CV here no later than June 26th 2019. ". If you have any questions to the position please do not hesitate to contact RA Manager Malene Barré Pedersen (53 55 35 01).