Specialist, Post Market Surveillance

Are you passionate about working with medical devices? Do you want to ensure that the products perform as intended and are continuously safe for the patients?
If so, you might be a good match as our new colleague in the Post Market Surveillance team atCook Medical. This is a unique opportunity to join a highly specialized team dedicated to monitoring product safety and ensuring regulatory compliance for our portfolio of lifesaving medical devices treating cardiovascular disease.

Your role as PMS specialist
We are looking for a colleague to join our PMS team in Regulatory Affairs. Here, you will become part of our ”One-team culture” valuing cross functional collaboration, and knowledge sharing to build a strong foundation for developing new products and maintaining existing solutions on global markets.

As a PMS specialist you will join our Regulatory Science Team consisting of two sub-teams dedicated to PMS and Clinical Evaluation, respectively. The position is office based (in Bjæverskov) but offers a high level of flexibility and the option to work from home 2-3 days per week.

You will be part of a two-person local PMS team (you being one of the two PMS Specialists) and a larger global team responsible for conducting and developing PMS activities, including implementation of activities related to the changing regulatory environment introduced by EU Medical Device Regulation (MDR) and UK MDR.

Day to day tasks for our PMS specialists include but are not limited to:

• Planning, coordinating and driving input for scheduled PMS activities to demonstrate the continued safety and performance of our medical devices.
• Facilitating and chairing quarterly product review meetings.
• Maintaining and completing PMS related documentation i.e. PMS plans and Periodic Safety Update Reports (PSURs) in compliance with global medical device regulations, e.g. EU MDR 745/2017, ISO 13485, and MDCG guidance documents.
• Provide input for PMS reporting in regions outside EU (e.g. UK, Canada and China).
• Overseeing and maintaining an in-depth understanding of regulatory requirements related to PMS for various markets.
• Maintaining the Quality Management System (QMS) related to PMS to reflect internal and external requirements.
• Maintaining and developing processes and work routines related to PMS in a local and global setting.
• Supporting correspondence with Regulatory Authority and Notified Body.
• Participating in external/internal audit activities as PMS subject matter expert.
• Provide cross functional PMS input as required in e.g. clinical evaluations, regulatory submissions and product development projects.

To be successful in this role you have a passion for PMS in medical device and would like to drive and develop these activities in a local and global setting. You thrive in a dynamic and fast paced environment and feels comfortable taking the lead in promoting such behavior. You are systematic, independent and have excellent collaboration skills.

Furthermore, we expect you to fulfill the following:
• As a minimum hold a bachelor’s degree in health care or engineering, within the medical or life sciences field or similar.
• Preferably have experience from a similar role(s), alternatively other experience from the medical device or pharmaceutical industry.
• Have excellent coordination and stakeholder management skills.
• Have a quality-oriented mindset and are dedicated to deliver on time.
• Have excellent verbal and written communication skills (Danish and English).

Cook as a workplace
Cook Medical is a family owned, American company with well over 10.000 employees worldwide. We invent, manufacture, and deliver unique medical devices to health care systems across the world. We believe that serving patients is a privilege and we demand the highest standards of quality, ethics, and service in everything we do.
In Denmark (WCE), we are approximately 700 colleagues at two sites in Bjæverskov and Ringsted, respectively.

At Cook Medical, we are proud of our special “Cook spirit”. Across the organization, you will be met with courtesy and pride of the quality of the work we carry out and the devices we develop. As a Cook employee, you contribute to the development of innovative, unique medical devices – we make a difference to patients all over the world on a daily basis.

We value qualities such as decisiveness, loyalty, and humor practiced in an open and friendly atmosphere. As a new Cook colleague, you are offered a well-organized internal onboarding program in order to get familiar with our company structure and your work assignments. Apart from a salary package comprising bonus and pension schemes, we offer a high degree of flexibility in planning of your daily work, and a standard package of equipment to set up your home office, favorable onsite canteen facilities, private health insurance, as well as a selection of voluntary activities and memberships including art association, sports association and free use of the company’s fitness center.

Does this look like a good match?
If you recognize yourself in this role, please send your application and summary via the below link at the earliest convenience and no later than March 12th 2025. We invite candidates into the recruitment process continuously and fill the position once we have found the right match.

If you have any questions related to the job, please feel free to reach out to Trine Højgaard Tølbøll, Manager PMS & CER at +45 25437978 or Trine.Toelboell@cookmedical.com.

For further information, please visit www.cookmedical.com

We look forward to hearing from you!