RA - Regulatory Manager for within Medical Supplies
Experis Engineering Huvudkontor / Elektronikjobb / Solna
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For one of costumer with in life science sector, we are searching for a consultant to take up the role as Regulatory Affairs Manager for a vacancy during a maternity leave period of minimum 9 months with a possibility to be extended.
As Regulatory Affairs Manager, you are responsible for the functioning of the post-market Regulatory Affairs activities within the Nordics. Your role includes the answering of regulatory questions from internal or external customers, coordination of requests from competent authorities, implementation of local regulatory requirements, etc. The consultant will ideally be based in our office in Solna, Sweden.
Principle Accountabilities of the Regulatory Manager
• Acts as a contact for complaints for all Nordic countries and follows-up on additional questions.
• Acts as a contact for the authorities for regulatory issues within his/her region, providing information.
• Approves or rejects new product requests for the Nordic countries based on local requirements.
• Implements corrective actions for the Nordic countries where required, based on the guidance from the General Business Unit, with responsibility to close the action in a timely matter.
• Work on ad-hoc Regulatory Affairs projects when required.
• Implements new regulatory requirements in the Nordics area.
• Monitors and communicates changes in the regulatory environment in the Nordics area.
• Represents Covidien in standardization groups and/or trade associations.
Minimum requirements of the Regulatory Manager
Bachelor's degree (or equivalent) in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering or a related discipline.
Minimum 3 to 5 years' experience in Regulatory Affairs or similar, preferably in Medical Devices.
Fluent in English, additional Nordic language is required. (Swedish, Norwegian, Danish)
Other Skills of the Regulatory Manager
Good computer skills, customer focused, result orientated, independent work style, team-minded, has an eye for details and works with the necessary diligence.
Application
Are you the talent we are looking for? Then apply for the consultant assignment by clicking on the link "Ansök nu". The applications will be evaluated continuously. The application shall contain a CV and Cover letter in English. So don't hesitate to apply as soon as possible.
For more information about the position please contact Gabriella Mjölnevik at
gabriella.mjolnevik@se.experis.com .
Publiceringsdatum2014-11-19Arbetstider och omfattning100% Enligt överenskommelse
ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2014-12-05
Klicka på denna länk för att göra din ansökanKontaktGabriella Mjölnevik
FöretagExperis Engineering Huvudkontor
AdressExperis Engineering Huvudkontor
Klarabergsgatan 29
11181 Stockholm
KontorsadressKlarabergsgatan 29
Jobbnummer 2073613
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