Post-Market Surveillance Specialist
Are you ready to take on our newly created position as Post-Market Surveillance Specialist? And are you interested in working in an educational and interdisciplinary environment?
To ensure continued Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) as an integrated part of the product lifecycle, we are looking for a new colleague having an interest in and preferably experience of PMS. PMS is well integrated and an interdisciplinary process, where various functions provide input to the process. One of the inputs to the PMS process is PMCF activities to collect clinical data proactively.
As a Post-Market Surveillance Specialist, you will be responsible for PMS of all the devices manufactured at William Cook Europe (WCE), covering devices in the Vascular and MedSurg business divisions within the specialty areas, Aortic Therapies, Venous Therapies, Peripheral Artery Disease Therapies, Embolic Therapies and Critical Care. You can learn more about our business divisions at www.cookmedical.eu.
As a Post-Market Surveillance Specialist, you will be based in the in Regulatory Affairs department, where you will join a team of 30 dedicated colleagues working with regulatory activities worldwide. We work closely together with other colleagues in the fields of development, clinical research, manufacturing, quality, and marketing as well as with colleagues of our main office in the US.
Your main responsibilities as a Post-Market Surveillance Specialist will be to:
- Maintain an excellent understanding of global medical device regulations in relation to PMS and Post-Market Clinical Follow-Up (PMCF)
- Monitor and implement requirements on a continuous basis to be in compliance with relevant requirements as per ISO13485, MDD 93/42/EEC, MDR 2017/745, FDA QSP 21CFR Part 820 and others as relevant
- Maintain appropriate records to demonstrate compliance with the applicable regulations like generating gap analysis, if needed
- Implement, maintain, and improve the PMS and PMCF processes for collection and evaluation of PMS data for all WCE devices. Perform all tasks in accordance with the Quality Management System
- Provide input and adherence to the scheduling and management of the PMS process and the PMCF process to make sure activities are followed through including process outputs and follow-up actions
- Liaise and advise other WCE functional areas (Sustaining, Engineering, Divisions, Quality, etc.) of the relevant requirements for PMS and PMCF and ensure that the process inputs from the individual functional areas meet the applicable regulatory requirements
- Facilitate the PMS meetings and collaborate with functional teams to collect, review, and analyze data for the PMS process, finalize the PMS report/Periodic Safety Update Report (PSUR), PMS Plan, and PMCF plan
- Collaborate with internal and external regulatory colleagues on PMS documentation and reply to questions from competent authorities for regulatory submissions worldwide
- Upload relevant documentation to the EUDAMED database to be in compliance with the MDR 2017/745
- Support the organization during internal and external audits.
To be successful in this role, you will need to have a genuine interest in PMS, and you thrive in a cross-functional setting. You find success in facilitating meeting and work tasks, quality process improvement, data management and compiling documentation.
As a Post-Market Surveillance Specialist, you are expected to have the following qualifications:
- A relevant scientific educational background, e.g., a degree in Life Science, Pharmaceutical Science, Nurse with scientific experience, or similar degree
- Preferably, previous experience of PMS and of working with different stakeholders
- Preferably, relevant quality, regulatory, or vigilance operational experience from the medical devices industry or pharmaceutical industry
- Excellent verbal and written communication skills in English and Danish.
Regulatory Affairs operates in a global environment which requires excellent communication skills and a flair for collaborating at all levels. You are organized and have an eye for detail while still the ability to juggle multiple tasks and projects across the organization in a thorough and systematic way. You are self-driven and work independently within your own areas of responsibility, and you can handle changes in prioritization of tasks. Importantly, we expect you to be an excellent team player with a positive and committed approach to your tasks. You wish to work in a global, yet local environment.
Cook Medical has a healthy company culture with a strong common set of values. Responsible, competent and professional staff is our most important resource. We have a flat organizational structure and focus on open dialogue. Qualities such as determination, loyalty and humor are highly appreciated.
The staff of Cook Medical helps to uphold the company’s philosophy of developing innovative medical solutions to raise the quality of patient treatment worldwide - every day, we make a difference.
Cook Medical offers a well-organized internal training course which is taken by all new staff to enable them to quickly gain thorough knowledge of the company.
In addition to a salary package with pension, we offer flex time, a bonus system, health insurance, as well as free use of the company’s own gym.
For further information about the job, please feel free to contact Mie Dyrholm, Manager Venous, PAD, Embolic Therapies and Critical Care, Regulatory Affairs by phone: +45 56 86 84 92 or e-mail: Mie.Dyrholm@cookmedical.com or Karin Nielsen, Manager Aortic Therapies, Regulatory Affairs by phone: +45 56 86 88 86 or e-mail: Karin.Nielsen@cookmedical.com.
Deadline for applications is July 28, 2019, and shortly after this date, the first interviews will take place.