Clinical & PMS Specialist
Ferrosan Medical Devices A/S
About Ferrosan Medical Devices A/S
Ferrosan Medical Devices A/S develops and produces a portfolio of hemostatic products to aid surgery minimizing bleeding challenges (Surgiflo®). Products are registered as medical devices (Class III) and are sold internationally in more than 100 countries in close collaboration with the main customer and innovation partner Ethicon, part of Johnson & Johnson. All main functions in the company are in Søborg, DK including production facilities, so everyone sits door to door with easy access to each other.
The company is growing and has a long-term strategy which involves several early innovation projects discovering the next generation hemostatic products.
Being on an innovation journey and MDR and more devices in the pipeline requires more RA employees and therefore we are looking for a Clinical & PMS Specialist capable of driving our clinical evaluation and PMS-activities and ensuring coordination across functions also with contact to our notified body. The department consists of 7 RA FTE’s including 1 employee responsible for Post Marketing Surveillance (PMS). You will report to the RA Director.
As Clinical and Post Market Surveillance Specialist you will set the standard and develop this new and important function in the company. You will work closely with several stakeholders such as 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.
You will be involved in many versatile tasks driving the PMS activities such as gathering cross-functional input and running quarterly meetings to achieve the necessary post market surveillance reports. You will also be involved with MDR activities and with maintaining documentation. The product innovation projects will require your participation when it comes to Clinical Evaluations Reports required for medical device classed to confirm the safety and performance of the device.
Working for a company the size of Ferrosan Medical Devices will at times also demand a pragmatic approach, so you need to know when to apply a perfect solution and go with the best option available.
In summary, your role will include:
- 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).
- 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.
- 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.
Ideal candidate profile
Ideally you have gathered experience from a similar role and would like to establish and set the standard for this new function at Ferrosan Medical Devices. You have a scientific background and clinical interest with a profound interest in investigating and collecting data and other evidence either from published scientific literature or clinical investigations preferable within medical devices or combination products. You are used to work both independently but also in collaboration with other functions with the ability to communicate complex issues in a clear way for everyone to understand.
The role requires:
- The successful candidate will have an academic background (master’s 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.
- Strong interpersonal skills, self-starting and collaborating personality.
- Ability to put own work into a cross-functional reference.
- Strong oral/written communication skills both Danish and English.
Ferrosan Medical Devices as a workplace
Ferrosan Medical Devices A/S is driven by a dedicated energetic organization with impressive growth. Our company has 230 employees covering all aspect of tasks related to product development and production of medical devices and combination products.
How to come into consideration
Peoplement offers executive search and recruitment of executives, senior managers, and key specialists primarily within general management, sales, digital, marketing, finance, supply chain & operations, R&D, HR and IT.
DK 2900 Hellerup, Denmark