Clinical Evidence Manager - Permanent
Cochlear Bone Anchored Solutions AB / Kemiingenjörsjobb / Härryda
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hela Sverige Cochlear Limited is the global market leader in implantable hearing solutions and is a top 100 global medical device company. Our global product range includes the world?s leading cochlear implant systems and the most advanced bone conduction hearing solutions. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people?s lives.
Key Responsibilities
We are seeking a Clinical Evidence Manager to join our Research & Applications department at the Cochlear Bone Anchored Solutions (CBAS) headquarters located in Mölnlycke, Sweden. Reporting to the Manager of Clinical and Pre-clinical Research this role works within cross-functional teams including clinical research professionals, product managers, quality and regulatory specialists, subject matter experts, etc. This role is responsible for clinical evidence planning, consolidation and dissemination of known clinical evidence through the initiation and completion of literature reviews, clinical evaluation reports and similar documents, compliant with CBAS quality procedures and regulatory requirements. As part of a cross-functional team, this role is an important contributor of input to clinical strategies, risk management activities, design of clinical and pre-clinical investigations, marketing materials, regulatory submissions and product development. In this permanent role you will have the opportunity to make a significant contribution to Cochlear's successful history of innovation by applying your knowledge of clinical evidence management.
Key Requirements
Demonstrated clinical and/or research experience -- preferably with medial devices
Experience in medical device or pharmaceutical industry ? 3 to 5 years minimum
Working knowledge of regulations (e.g. MEDDEV 2.7.1, MDD 93/42/EEC, AIMDD 90/385/EEC, ISO13485, FDA 21CFR820)
Clear and effective communication skills
Well-developed report and technical writing skill in the English language, ideally with experience from performing literature reviews and/or writing clinical evaluation reports
Ability to work independently and to manage clinical evidence across multiple projects
Analytical thinking and a scientific mindset
Qualification in biology, engineering, medicine, or similar
Working at Cochlear BAS:
Cochlear BAS is a division of Cochlear Ltd and the world leader in bone conduction hearing solutions. Situated in Mölnlycke, outside Gothenburg, Sweden, the head office employs over 200 people whose responsibilities include research, product design and development, marketing, quality and regulatory, manufacturing, distribution and administration for all the Baha® and Vistafix® products. Cochlear Bone Anchored Solutions AB offers you an innovative environment in which you can work with passionate professionals to apply your specialist expertise and skills to bring the most advanced technologies to the market.
As a world-leader in innovative medical devices, Cochlear encourages continuous learning and career development for employees globally. Visit
www.cochlear.com/careers for more information.
Cochlear, Hear now. And always, Nucleus, and the elliptical logo are either trademarks or registered trademarks of Cochlear Limited.
Publiceringsdatum2015-02-20Arbetstider och omfattningTillsvidare
Heltid
ErsättningFast månads- vecko- eller timlön
Så ansöker duSista dag att ansöka är 2015-03-09
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FöretagCOCHLEAR BONE ANCHORED SOLUTIONS AB
AdressCOCHLEAR BONE ANCHORED SOLUTIONS AB
BOX 82
43522 MÖLNLYCKE
KontorsadressKONSTRUKTIONSVÄGEN 14
MÖLNLYCKE
Visa på karta
Övriga kontaktuppgifterTelefonnummer: 031-7924400
Jobbnummer 2175713
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