Manager, Regulatory Affairs in the Medical Device Industry

Do you want to take the lead and manage a team of skilled employees working in a local and global context within regulatory affairs in a medical device company ensuring high level treatment of patients suffering from blood vessel diseases worldwide?

Become a part of Cook Medical

We are excited to announce this opportunity to join our Regulatory Affairs team as we are looking for a skilled and committed colleague to lead our dynamic and highly competent team of Regulatory Specialists.

You set the direction and make a clear impact

The overall Regulatory Affairs department comprises 25 dedicated colleagues across 4 specialized teams. As manager of the regulatory specialists, you will be responsible for guiding and developing a team of highly skilled professionals who work across all aspects of regulatory activities related to the approval of medical devices. This includes managing regulatory submissions, establishing and maintaining regulatory systems, and supporting product registration and change management throughout the product lifecycle.

Your role will involve setting the strategic framework and direction for the team’s activities, ensuring alignment with organizational goals and navigating the complex regulatory landscape effectively. You will collaborate with internal and external stakeholders to facilitate successful approvals, ensure compliance, and drive regulatory processes forward. This may also require engaging in in-depth strategic projects where your expertise and leadership are critical to success.

As a leader, your focus will extend beyond daily operations to developing and coaching your team members. You will foster a culture of growth and innovation, helping individuals overcome challenges and realize their potential. You will be instrumental in defining and implementing the strategic vision, equipping the team to address both short-term demands and long-term objectives.

There are numerous interfaces within the organization, and your stakeholder management skills will be essential in establishing ongoing dialogue and collaboration with global and local teams across Cook.

In summary, you will be the driver of strategic direction, enabling your team to deliver high-quality regulatory solutions on both a local and global scale.

A leader with knowledge of medical devices and regulations

You will be part of the Regulatory Affairs Management team and the larger team of managers at the site. Furthermore you will have collaborations across our global Cook network. Leadership is key to our agenda, and together we drive and develop the organization.

To succeed in this role, it is vital that you are a true collaborator and that you lead by example in everything you do.

You will support and empower your employees in their development and acknowledge their strengths and accomplishments.

Furthermore, we expect that you:

• Have experience in management roles or be ready to transition into one
• Understand medical devices, EU MDR, and have experience within regulatory affairs
• Speak and write English effortlessly

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 the health care systems of the world. Serving patients is a privilege and we demand the highest standards of quality, ethics, and service in all that we do.

In Denmark, we are approximately 700 colleagues based in Bjaeverskov and Ringsted, respectively.

At Cook Medical, we are proud of our special ”Cook spirit”. All over the organization, you are 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 – and we are aware that we make a difference to patients all over the world every day.

We appreciate qualities such as decisiveness, loyalty, and humor and work for an open dialog.

As a new Cook colleague, you are offered a well-organized internal training course enabling you to quickly gain a thorough knowledge of the company. Apart from a salary package comprising bonus and pension schemes, we offer a high degree of flexibility in the planning of your daily work with the assignments in focus, equipment for teleworking, a good canteen when you are onsite, health assurance, and activities such as an Arts’ Society, a Sports’ Society and free use of the company’s own fitness center.

Interested?

 If you recognize yourself in this role, please send your application and CV at the earliest convenience and by September 12 at the latest. We review applications and invite candidates into the recruitment process continuously and fill the position once we find the right match

Please feel free to contact Mie Dyrholm, Director of Regulatory Affairs at +45 5686 8886 or mie.dyrholm@coookmedical.com if you have any questions related to the job.

For further information, please visit www.cookmedical.com

We look forward to hearing from you!