Regulatory Affairs Specialist
We are looking for a new colleague for our Regulatory Affairs team. The purpose is to ensure that continued regulatory work is an integrated part of the product lifecycle.
As a Regulatory Affairs Specialist 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 at our main office in the US.
In Regulatory Affairs, we provide support to the Vascular and MedSurg business divisions within the specialty areas of 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.
Your main responsibilities will be:
- Collecting and preparing relevant documentation and communicate with regulatory authorities to ensure approval of William Cook Europe’s devices for CE-mark, USA, Canada, Australia, China, Korea, and Japan
- Ensuring regulatory compliance and providing regulatory strategies for e.g. design changes or introducing new regulatory requirements throughout the lifecycle of the devices
- Providing input and facilitating the Post Market Surveillance process and providing regulatory input to Post Market Surveillance
- Providing regulatory assessment of changes
- Gaining and maintaining a high level of competence within international regulatory requirements for medical devices for the above countries
- Participating in product development projects and providing regulatory input to the regulatory strategy
- Collaborating with internal and external regulatory colleagues on submissions
- Conducting regulatory review and approval of product documentation and marketing materials
You are expected to have the following qualifications:
- A scientific educational background, e.g., a degree in Life Science, Pharmaceutical Science, Engineering or other relevant background
- Preferably, an understanding of the regulatory requirements for medical devices (MDD 93/42/EEC and FDA 21 CFR, Part 820)
- Preferably experience from the medical device or pharmaceutical industry
- Preferably knowledge and understanding of regulatory requirements for medical devices
- 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 in a global, yet local environment. You have a keen eye for detail while still the ability to juggle multiple tasks and projects across the organization in a thorough and systematic way. It is obvious that you work independently within your own areas of responsibility. Importantly, we expect you to be an excellent team player with a positive and committed approach to your assignments.
Cook Medical’s company culture is based on a set of strong common values where responsible, competent and professional employees are 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.
Cook Medical’s employees help uphold the company’s philosophy of developing innovative medical solutions to raise the quality of patient treatment worldwide - we make a difference every day.
In addition to a salary package including pension, we offer flex time, a bonus system, health insurance, and free use of the company’s gym.
Please contact Karin Nielsen, Manager, Aortic Therapies, Regulatory Affairs at +45 56 86 88 86 or Karin.Nielsen@cookmedical.com
Deadline for applications is August 12, 2018