Specialist, Regulatory Reporting, Regulatory Affairs - Temporary position
The regulatory reporting team of William Cook Europe’s Regulatory Affairs department in Denmark is looking for an employee for a temporary position as one of our team members is going on maternity leave. This temporary position should be filled as of December 1, 2018 and will last until December 2019.
In the Regulatory Reporting Regulatory Affairs department, we are 7 dedicated employees working with regulatory reporting activities regarding medical devices. We work in an informal environment together with experienced colleagues in-house within the fields of, e.g., clinical, quality assurance and marketing. Likewise, we collaborate with colleagues from other Cook Medical companies globally.
With your acquired in-depth knowledge of Cook Medical’s devices and your understanding of the relevant legislation, you will be a key player in ensuring qualified reporting and communication to competent authorities (eMDR, Vigilance, etc.)
Your main responsibilities as a Specialist, Regulatory Reporting will be:
- Participate in the daily handling of new complaints
- Assessing complaints for regulatory adverse event reporting
- Submission of reports to appropriate competent authorities
- Handling and coordinating the communication with competent authorities related to complaint handling
- Internal, administrative activities related to regulatory adverse event reporting
- Assistance in coordination of administrative recall activities
- Ensuring that relevant legislation is being processed and implemented.
As a Specialist, Regulatory Reporting, you are expected to have the following qualifications:
- A scientific, educational background, e.g., a degree in Life Science, Pharmaceutical Science, Engineering, Nursing or other relevant background or other relevant experience with the medical device industry
- Excellent communication skills and fluency in verbal and written English and Danish.
You have good interpersonal skills, an eye for detail and the ability to work independently with your own areas of responsibility. Importantly, we expect you to be an excellent team player with a positive and committed approach to your tasks.
You have excellent communication skills at all levels and the wish to work in a global, yet local environment.
Recently qualified candidates are encouraged to apply.
William Cook Europe offers
William Cook Europe’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 humour are highly appreciated.
The team 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.
In addition to a salary package with pension, we offer flex time, a bonus system, health insurance and free use of the company’s own gym.
For further information about the position, please contact Thomas Kirk, Team lead, Regulatory Reporting, Regulatory Affairs, phone: +45 56 86 89 92/e-mail: firstname.lastname@example.org.
Please upload your application and CV no later than October 14, 2018.